Use of a Loading Dose of Vitamin D for Treatment of Vitamin D Deficiency in Patients With Intestinal Failure

Vitamin D deficiency is common in patients with intestinal failure and short bowel syndrome who have been weaned of parenteral nutrition. Dietary supplementation with vitamin D is necessary to correct this deficiency. In certain cases, routine supplementation strategy may be ineffective. We report 3 cases of vitamin D deficiency in patients with intestinal failure who showed improvement in serum 25‐hydroxyvitamin D levels after supplementation with a loading dose of 20,000–40,000 IU vitamin D provided weekly.     

Prevalence of vitamin D deficiency and response to oral vitamin D supplementation in patients receiving home parenteral nutrition

The purpose of this study was to document vitamin D status in home parenteral nutrition (HPN) patients and determine if oral vitamin D supplementation has a substantial effect. Methods: A retrospective chart review of eligible adults enrolled in the Southern Alberta Home Parenteral Nutrition program (n = 15) for a minimum of 6 months was conducted. Serum measurements of 25OHD were recorded and patients were categorized by vitamin D status as follows: sufficient; insufficient; deficient with respective levels of 25OHD ≥75 nmol/L, 27.5–75 nmol/L, and ≤27.5 nmol/L; and mixed. Results: Five of 15 patients had insufficient vitamin D status throughout the study period; all had short bowel syndrome. Nine were in the mixed category; 1 was consistently sufficient, and no one was consistently deficient. Patient demographics were similar between the insufficient and mixed groups. There were no significant differences in health outcomes between the insufficient and mixed vitamin D status groups. The median (interquartile range) dose and duration of vitamin D3 supplementation for the insufficient group was 5000 IU/d (4,000–7,143) for 1,175 (1,145–1,578) total days compared to 3,000 IU/d (1,000–7,143) for 1,529 (111–1,980) days for the mixed group. Conclusions: Most patients receiving HPN had insufficient vitamin D status. When prescribed high doses of oral vitamin D, patients did not consistently achieve appropriate 25OHD levels. Alternate routes of vitamin D supplementation in patients receiving HPN should be considered. Large multicenter prospective studies are needed to best characterize the relationship between vitamin D dosing for HPN patients and vitamin D status.     

Vitamin D Deficiency in Children With Intestinal Failure Receiving Home Parenteral Nutrition

Background: Vitamin D plays important roles in both skeletal and nonskeletal health. Limited data suggest that patients with intestinal failure (IF) receiving home parenteral nutrition (PN) are at risk for vitamin D deficiency due to inadequate oral intake, poor absorption, and chronic illness. The purpose of this study was to document vitamin D status in pediatric patients with IF receiving home PN. Materials and Methods: We performed a 2‐year retrospective review of children with IF followed at our center who had been on home PN for ≥6 months and had ≥1 serum 25‐hydroxyvitamin D (25‐OHD) level checked as part of routine clinical care. Patients were then categorized as deficient (<20 ng/mL), insufficient (20–29 ng/mL), or normal (≥30 ng/mL) based on their lowest vitamin D level. Demographic data and clinical characteristics were also assessed. Results: Eleven of 27 children (41%) had ≥1 insufficient 25‐OHD level, including one child with vitamin D deficiency. Diagnosis of short bowel syndrome (compared with dysmotility or malabsorption syndromes) was associated with decreased likelihood of suboptimal vitamin D status, with an odds ratio of 0.12 (95% confidence interval, 0.02–0.8, P = .028). Osteopenia was noted in 59% of the cohort. There was a trend toward higher risk for osteopenia in patients with low 25‐OHD levels compared with those with normal 25‐OHD levels (82% vs 44%, P = .109). Conclusion: Suboptimal 25‐OHD levels are common in children with IF on home PN. This emphasizes the critical importance of routine surveillance of serum vitamin D levels and consideration of enteral supplementation when indicated.     

The Canadian Home Total Parenteral Nutrition (HTPN) Registry: vitamin K supplementation and bone mineral density

Background: Vitamin K supplementation improves bone health, and its absence might be associated with low bone mineral density (BMD). The authors aim to assess vitamin K supplementation practices in Canadian home parenteral nutrition (HPN) programs and their relationship with BMD. Methods: This is a cross‐sectional study of 189 patients from the Canadian HPN registry. Results: All 189 patients studied received M.V.I.‐12, which does not contain vitamin K. Of those, 41.3% were supplemented with 10 mg of intravenous vitamin K (VK+) weekly, whereas the others did not receive vitamin K except via lipid emulsion (VK?). Short bowel syndrome accounted for 69% of VK+ and 46% of VK? patients. On univariate analysis, VK+ patients had substantially lower body mass index (BMI) and received lower bisphosphonate infusion than did VK?patients. There were no statistically significant differences in HPN calcium or lipid content, liver function test results, age, sex, or reason for HPN between the 2 groups. Patients who were VK+ had higher lumbar spine T scores and hip T scores than did VK?patients. General linear modeling analysis, adjusted for BMI, age, PN magnesium, PN phosphate, PN calcium, and bisphosphonate as possible predictors of BMD, showed a trend toward better hip T scores (P = .063) for VK+ patients compared with VK? patients. Conclusion: In HPN patients supplemented with vitamin K, the trend toward a better hip BMD compared with no supplementation suggests a role for vitamin K in preserving BMD. This requires further study.     

Clinical Trial of Vitamin D2 vs D3 Supplementation in Critically Ill Pediatric Burn Patients

Background: Hypovitaminosis D exists postburn. However, evidence‐based guidelines for vitamin D repletion are unknown. This investigation examined differences between D₂ and D₃ supplementation on outcome in children with burn injuries. Methods: Fifty patients with total body surface area burn of 55.7% ± 2.6% and full‐thickness injury of 40.8% ± 3.8% were enrolled, ranging in age from 0.7–18.4 years. All participants received multivitamin supplementation per standardized clinical protocol. In addition, 100 IU/kg D₂, D₃, or placebo was administered daily during hospitalization using a randomized, double‐blinded study design. Assay of total 25‐hydroxyvitamin D (D25), 1,25‐dihydroxyvitamin D (D1,25), 25‐hydroxyvitamin D₂ (25‐OH‐D₂), 25‐hydroxyvitamin D₃ (25‐OH‐D₃), and parathyroid hormone (PTH) was performed at 4 preplanned time intervals (baseline, midpoint, discharge, and 1 year postburn). Differences in vitamin D status were compared over time and at each specific study interval. Results: There were no significant differences in serum vitamin D levels between groups, but >10% of patients had low D25 at discharge, and percent deficiency worsened by the 1‐year follow up for the placebo (75%), D₂ (56%), and D₃ (25%) groups. There were no statistical differences in PTH or clinical outcomes between treatment groups, although vitamin D supplementation demonstrated nonsignificant but clinically relevant decreases in exogenous insulin requirements, sepsis, and scar formation. Conclusions: The high incidence of low serum D25 levels 1 year following serious thermal injury indicates prolonged compromise. Continued treatment with vitamin D₃ beyond the acute phase postburn is recommended to counteract the trajectory of abnormal serum levels and associated morbidity.     

Vitamin D Deficiency in Patients With Neuromuscular Diseases With Chronic Respiratory Failure

Background: The prevalence and clinical implications of vitamin D deficiency have never been studied in patients with underlying neuromuscular diseases complicated with chronic respiratory failure. The aim of this study is to demonstrate the prevalence of vitamin D deficiency, its relationship with other bone markers, and mode of nutrition. Materials and Methods: Serum 25‐hydroxyvitamin D (25[OH]D) levels along with calcium, serum albumin, and phosphorus levels were obtained from 57 patients with chronic respiratory failure due to underlying neuromuscular diseases. These levels were obtained during their first visit to a chronic respiratory diseases clinic. Data with regard to nutrition, respiratory muscle function, and level of mobility were also obtained at the same time. Results: Seventy‐five percent of patients had serum 25(OH)D levels ≤30 ng/mL. There is a negative correlation between parathyroid hormone and 25(OH)D levels (P = .006) and corrected calcium levels (P = .066). Serum 25(OH)D levels varied with the mode of nutrition. Patients on enteral nutrition had the highest serum levels of 25(OH)D, whereas combined oral and tube feeds had the lowest 25(OH)D levels (P = .006). Conclusion: Low serum 25(OH)D levels are highly prevalent in patients with neuromuscular disease and chronic respiratory failure. The route of nutrition has an impact on these levels.     

Single high-dose vitamin D at birth corrects vitamin D deficiency in infants in Mexico

Abstract

This study examined the prevalence of vitamin D deficiency in mothers and infants in Tijuana, Mexico and determined the effect of a single oral dose of 50?000?IU vitamin D₃ at birth on 25-hydroxyvitamin D (25[OH]D) levels during infancy. Healthy infants were randomized to receive vitamin D₃ or placebo at birth. At birth 23% of infants were vitamin D deficient and 77% had vitamin D insufficiency (mean 25[OH]D level 18.9?ng/ml); 10% of mothers were vitamin D deficient and 61% were insufficient. Infants receiving vitamin D₃ had higher 25(OH)D levels at two months (N?=?29; 33.9 versus 24.2?ng/ml) and six months (N?=?21; 36.5 versus 27.4?ng/ml). Exclusively breastfed infants had lower 25(OH)D levels at two months (14.9 versus 33.4?ng/ml). Vitamin D deficiency is common in infants and mothers in Tijuana, Mexico. A single dose of vitamin D₃ at birth was safe and significantly increased 25(OH)D levels during infancy.     

Vitamin D status in autism spectrum disorders and the efficacy of vitamin D supplementation in autistic children

Objectives: Autism spectrum disorder (ASD) is a developmental disorder characterized by pervasive deficits in social interaction, impairment in verbal and non-verbal communication, and stereotyped patterns of interests and activities. Vitamin-D deficiency was previously reported in autistic children. However, the data on the relationship between vitamin D deficiency and the severity of autism are limited.

Methods: We performed a case–controlled cross-sectional analysis conducted on 122 ASD children, to assess their vitamin D status compared to controls and the relationship between vitamin D deficiency and the severity of autism. We also conducted an open trial of vitamin D supplementation in ASD children.

Results: Fifty-seven percent of the patients in the present study had vitamin D deficiency, and 30% had vitamin D insufficiency. The mean 25-OHD levels in patients with severe autism were significantly lower than those in patients with mild/moderate autism. Serum 25-OHD levels had significant negative correlations with Childhood Autism Rating Scale (CARS) scores. Of the ASD group, 106 patients with low-serum 25-OHD levels (<30?ng/ml) participated in the open label trial. They received vitamin D3 (300?IU/kg/day not to exceed 5000 IU/day) for 3 months. Eighty-three subjects completed 3 months of daily vitamin D treatment. Collectively, 80.72% (67/83) of subjects who received vitamin D3 treatment had significantly improved outcome, which was mainly in the sections of the CARS and aberrant behavior checklist subscales that measure behavior, stereotypy, eye contact, and attention span.

Conclusion: Vitamin D is inexpensive, readily available and safe. It may have beneficial effects in ASD subjects, especially when the final serum level is more than 40?ng/ml.

Trial registration number: UMIN-CTR Study Design: trial Number: R000016846.     

Vitamin D insufficiency in children, adolescents, and young adults with cystic fibrosis despite routine oral supplementation

BACKGROUND: Cystic fibrosis (CF) with pancreatic insufficiency is associated with poor absorption of fat and fat-soluble vitamins, including vitamin D. Pancreatic enzyme supplementation does not completely correct fat malabsorption in CF patients. OBJECTIVE: The objective of the study was to compare the vitamin D status of children, adolescents, and young adults with CF who were treated with routine vitamin D and pancreatic enzyme supplements with the vitamin D status of a healthy reference group from a similar geographic area. DESIGN: Growth, dietary intake, and serum concentrations of 25-hydroxyvitamin D [25(OH)D], 1,25-dihydroxyvitamin D [1,25(OH)(2)D], and parathyroid hormone (PTH) were measured in 101 white subjects with CF and a reference group of 177 white subjects. RESULTS: The median daily vitamin D supplementation in the CF group was 800 IU. The mean +/- SD serum concentrations of 25(OH)D were 20.7 +/- 6.5 ng/mL in the CF group and 26.2 +/- 8.6 ng/mL in the reference group (P < 0.001). Vitamin D deficiency and insufficiency were defined as 25(OH)D concentrations < 11 ng/mL and < 30 ng/mL, respectively. Seven percent of the CF group and 2% of the healthy reference group were vitamin D deficient (P < 0.03). Ninety percent of the CF group and 74% of the healthy reference group were vitamin D insufficient (P < 0.01). Twenty-five percent of the CF group and 9% of the healthy reference group had elevated PTH (P < 0.006). The odds of vitamin D insufficiency in the CF group, compared with the healthy reference group, were 1.2 (95% CI: 1.1, 1.3) after adjustment for season and age. CONCLUSION: Despite daily vitamin D supplementation, serum 25(OH)D concentrations remain low in children, adolescents, and young adults with CF.     

Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life

Background: Vitamin D deficiency is common in inflammatory bowel disease (IBD). The aim of the study was to determine the prevalence and predictors of vitamin D deficiency in an IBD cohort. It was hypothesized that vitamin D deficiency is associated with increased disease activity and lower health‐related quality of life (HRQOL). Methods: This was a retrospective cohort study. Harvey‐Bradshaw index and ulcerative colitis disease activity index were used to assess disease activity. Short Inflammatory Bowel Disease Questionnaire scores were used to assess HRQOL. Multivariate logistic regression was used to identify independent predictors of vitamin D deficiency and its association with disease activity and HRQOL. Results: The study included 504 IBD patients (403 Crohn's disease [CD] and 101 ulcerative colitis [UC]) who had a mean disease duration of 15.5 years in CD patients and 10.9 years in UC patients; 49.8% were vitamin D deficient, with 10.9% having severe deficiency. Vitamin D deficiency was associated with older age (P = .004) and older age at diagnosis (P = .03). Vitamin D deficiency was associated with lower HRQOL (regression coefficient –2.21, 95% confidence interval [CI], –4.10 to –0.33) in CD but not UC (regression coefficient 0.41, 95% CI, –2.91 to 3.73). Vitamin D deficiency was also associated with increased disease activity in CD (regression coefficient 1.07, 95% CI, 0.43 to 1.71). Conclusions: Vitamin D deficiency is common in IBD and is independently associated with lower HRQOL and greater disease activity in CD. There is a need for prospective studies to assess this correlation and examine the impact of vitamin D supplementation on disease course.     

Comprehensive Safety Monitoring of 12‐Month Daily 7000‐IU Vitamin D3 Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults

Background: There is uncertainty whether long‐term daily dosing with vitamin D₃ (cholecalciferol) supplementation (vitD₃) above the 4000‐IU/d dietary reference intake upper tolerable limit in children and adults is safe. As part of a randomized placebo‐controlled trial, we determined if supplementation with 7000‐IU/d vitD₃ for 12 months in human immunodeficiency virus (HIV)–Infected subjects was safe and/or associated with metabolic outcomes. Material and Methods: A total of 58 HIV‐infected subjects—aged 9–24.9 years and stratified by mode of HIV acquisition (perinatal or behavioral)—were recruited, randomized to 7000‐IU/d vitD₃ or placebo, and followed at 3, 6, and 12 months with physical examinations, blood and urine sampling for measures of 25(OH)D (serum 25‐hydroxyvitamin D), metabolic status, safety measures, and HIV immune status. Safety was defined by a low incidence (<5%) of the study‐defined serious adverse events—that is, elevated serum calcium plus 25(OH)D >160 ng/mL—and no changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status. Results: Randomization groups did not differ in demographic characteristics, vitamin D status, or HIV disease status at baseline. Over the 12 months, serum 25(OH)D increased with supplementation. No subject experienced a serious adverse safety event; none had 25(OH)D >80 ng/mL at any time. There were no clinically significant changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status. Conclusions: Safety of daily 7000‐IU vitD₃ supplementation in children and young adults with HIV was comprehensively monitored over 12 months. High‐dose daily vitD₃ supplementation was efficacious in improving vitamin D status, and there were no safety events.     

Vitamin D Intake May Reduce SARS-CoV-2 Infection Morbidity in Health Care Workers

In the last 2 years, observational studies have shown that a low 25-hydroxyvitamin D (25(OH)D) level affected the severity of infection with the novel coronavirus (COVID-19). This study aimed to analyze the potential effect of vitamin D supplementation in reducing SARS-CoV-2 infection morbidity and severity in health care workers. Of 128 health care workers, 91 (consisting of 38 medical doctors (42%), 38 nurses (42%), and 15 medical attendants (16%)) were randomized into two groups receiving vitamin D supplementation. Participants of group I (n = 45) received water-soluble cholecalciferol at a dose of 50,000 IU/week for 2 consecutive weeks, followed by 5000 IU/day for the rest of the study. Participants of group II (n = 46) received water-soluble cholecalciferol at a dose of 2000 IU/day. For both groups, treatment lasted 3 months. Baseline serum 25(OH)D level in health care workers varied from 3.0 to 65.1 ng/mL (median, 17.7 (interquartile range, 12.2; 24.7) ng/mL). Vitamin D deficiency, insufficiency, and normal vitamin D status were diagnosed in 60%, 30%, and 10%, respectively. Only 78 subjects completed the study. Vitamin D supplementation was associated with an increase in serum 25(OH)D level, but only intake of 5000 IU/day was accompanied by normalization of serum 25(OH)D level, which occurred in 53% of cases. Neither vitamin D intake nor vitamin D deficiency/insufficiency were associated with a decrease in SARS-CoV-2 morbidity (odds ratio = 2.27; 95% confidence interval, 0.72 to 7.12). However, subjects receiving high-dose vitamin D had only asymptomatic SARS-CoV-2 in 10 (26%) cases; at the same time, participants who received 2000 IU/day showed twice as many SARS-CoV-2 cases, with mild clinical features in half of them.     

Plasma 25‐Hydroxyvitamin D Levels at Initiation of Care and Duration of Mechanical Ventilation in Critically Ill Surgical Patients

Objective: Limited data exist regarding the relationship between plasma 25‐hydroxyvitamin D levels and duration of respiratory support. Our goal was to explore whether vitamin D status at the time of intensive care unit (ICU) admission is associated with duration of mechanical ventilation in critically ill surgical patients. Materials and Methods: We analyzed data from a prospective cohort study involving 210 critically ill surgical patients. To explore the relationship between admission plasma 25‐hydroxyvitamin D levels and duration of mechanical ventilation, we performed a Poisson regression while controlling for clinically relevant covariates. Only patients who required ≥48 hours of mechanical ventilation and survived ≥24 hours after discontinuation of respiratory support were included in the analytic cohort. Results: Ninety‐four patients met inclusion criteria. Mean (standard deviation) plasma 25‐hydroxyvitamin D level was 16 (7) ng/mL and median (interquartile range) duration of mechanical ventilation was 4 (2–7) days. Poisson regression analysis, adjusted for age, sex, race, body mass index, primary surgical service, Acute Physiology and Chronic Health Evaluation II score, and season of ICU admission, demonstrated an inverse association of plasma 25‐hydroxyvitamin D levels with duration of mechanical ventilation (incident rate ratio per 10 ng/mL, 0.66; 95% confidence interval, 0.54–0.82). Conclusions: In our cohort of critically ill surgical patients, plasma 25‐hydroxyvitamin D levels measured on ICU admission were inversely associated with the duration of respiratory support. Randomized controlled trials are needed to assess whether vitamin D supplementation can influence duration of mechanical ventilation in surgical ICU patients.     

Body Size and Serum 25 Hydroxy Vitamin D Response to Oral Supplements in Healthy Older Adults

Background: Vitamin D insufficiency is prevalent in the northeast United States. Since vitamin D insufficiency is readily amenable to supplementation, it is important to understand what factors are associated with serum 25 hydroxy vitamin D (25(OH)D) response to vitamin D supplementation.

Objective: In this study we examined the association of serum 25(OH)D response to vitamin D supplementation with body size in a population of elderly subjects.

Methods: 257 healthy, ambulatory men and women 65 years of age or older were randomly assigned to treatment with either 700 IU/day (17.5 μg/d) of supplemental vitamin D₃ and 500 mg/day (12.5 mmol/d) of supplemental calcium, or to placebo.

Results: In multivariate regression analyses, after adjusting for baseline 25(OH)D, season, and sex, we found change in 25(OH)D to be inversely associated with baseline BMI (p = 0.01) in subjects treated with supplements for one year. Change in 25(OH)D was also negatively associated with other baseline anthropometric measurements in these subjects.

Conclusion: Our study implies that body size should be taken into account when estimating the amount of vitamin D intake needed to raise 25(OH)D to the desired level.     

Relationship of Vitamin D Deficiency to Clinical Outcomes in Critically Ill Patients

Background: Despite the numerous disease conditions associated with vitamin D deficiency in the general population, the relationship of this deficiency to outcome in critically ill patients remains unclear. The objective of this study is to determine the burden of vitamin D deficiency in intensive care unit (ICU) patients and determine if it is associated with poor patient outcomes. Methods: The authors conducted an analysis of samples collected from a prospective study of 196 patients admitted to a medical/surgical ICU in a tertiary care hospital. They measured serum 25‐hydroxyvitamin D at admission and up to 10 days following admission and followed patients prospectively for 28‐day outcomes. Results: Of analyzable patients, 50 (26%) were deficient (≤30 nmol/L) and 109 (56%) were insufficient (>30 and ≤60 nmol/L). Baseline 25(OH)D levels decreased significantly in all patients after 3 days in the ICU and remained significantly lower through 10 days (P < .001). 25(OH)D status was not significantly associated with 28‐day all‐cause mortality (hazard ratio [HR], 0.89; 95% confidence interval, [CI] 0.37–2.24). Higher levels of 25(OH)D were associated with a shorter time‐to‐alive ICU discharge (HR, 2.11; 95% CI, 1.27–3.51). 25(OH)D‐deficient patients showed a nonstatistically significant trend toward a higher infection rate (odds ratio [OR], 3.20; 95% CI, 0.784–13.07; P = .11) compared with patients with sufficient levels of 25(OH)D. Conclusions: This study demonstrates significant decreases in vitamin D status over the duration of the patient's ICU stay. Low levels of vitamin D are associated with longer time to ICU discharge alive and a trend toward increased risk of ICU‐acquired infection.     

Effect of Discontinuation of Manganese Supplementation From Home Parenteral Nutrition Solutions on Whole‐Blood Levels and Magnetic Resonance Imaging of the Brain: A 5‐Year Cohort Study

Background: Manganese (Mn) is included in current premixed multiple trace element (TE) additives for home parenteral nutrition (HPN). However, there is a risk of oversupplementation of Mn due to contamination from PN additives. Oversupplementation can produce Mn toxicity with neurologic symptoms and abnormalities on brain magnetic resonance imaging (MRI). In 2009, we reported that whole‐blood Mn levels were above the upper limit of normal in 16 HPN patients, with 81% having MRI findings. Subsequently, we removed Mn supplementation from all our HPN patients. We present a 5‐year follow‐up here. Methods: This is a prospective cohort study on 11 of the surviving 16 patients on HPN. All patients had Mn removed from PN and had yearly monitoring of blood Mn levels. Eight patients had a repeat MRI to evaluate for resolution of basal ganglia deposits. Patient demography, clinical history, and bloodwork were recorded. Results: Five of 6 patients who initially had elevated Mn levels had normal levels on follow‐up. All patients who had Mn levels measured serially had a decrease in levels; the mean percent decrease of Mn was 38.1% (range, 10.1%–53.8%). Two patients had elevated Mn despite the absence of supplementation. Six of 8 patients who had repeat MRIs had complete resolution abnormalities. Conclusions: Removal of Mn as an additive in HPN solutions resulted in resolution of MRI abnormalities in most patients. Over 5 years, all patients except for 1 maintained normal blood Mn levels. Therefore, Mn levels should be monitored and supplementation be individualized.     

Iron Deficiency in Long‐Term Parenteral Nutrition Therapy

Background: Iron is not routinely added to parenteral nutrition (PN) formulations in the United States because of the risk of anaphylaxis and concerns about incompatibilities. Studies have shown that iron dextran in non‐lipid‐containing PN solutions is safe. Data are limited on iron status, prevalence of iron deficiency anemia (IDA), and efficacy of intravenous iron infusion in long‐term home PN (HPN). We aimed to determine the incidence of IDA and to examine the effectiveness of parenteral iron replacement in patients receiving HPN. Methods: Medical records of patients receiving HPN at the Mayo Clinic from 1977 to 2010 were reviewed. Diagnoses, time to IDA development, and hemoglobin, ferritin, and mean corpuscular volume (MCV) values were extracted. Response of iron indices to intravenous iron replacement was investigated. Results: Of 185 patients (122 women), 60 (32.4%) were iron deficient. Five patients were iron deficient, and 18 had unknown iron status before HPN. Of 93 patients who had sufficient iron storage, 37 had IDA development after a mean of 27.2 months (range, 2–149 months) of therapy. Iron was replaced by adding maintenance iron dextran to PN or by therapeutic iron infusion. Patients with both replacement methods had significant improvement in iron status. With intravenous iron replacement, mean ferritin increased from 10.9 to 107.6 mcg/L (P < .0001); mean hemoglobin increased from 11.0 to 12.5 g/dL (P = .0001); and mean MCV increased from 84.5 to 89.0 fL (P = .007). Conclusions: Patients receiving HPN are susceptible to IDA. Iron supplementation should be addressed for patients who rely on PN.     

Denosumab Improves Bone Mineral Density in Patients With Intestinal Failure Receiving Home Parenteral Nutrition: Results From a Randomized,Controlled Clinical Trial

Aim : Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D, and bisphosphonates have been used to treat BMD but with low efficiency due to their limited absorption and patient compliance. Denosumab is a new drug that helps prevent osteoclast development and activation and led to decreased bone resorption in some studies. The aim of this study was to assess its value in HPN patients. Methods : Between November 2011 and March 2013, 49 patients receiving HPN (29 women, 20 men, mean age 55.3 years) who met the eligibility criteria were randomly assigned to a denosumab or control group. Regional dual‐energy x‐ray absorptiometry of the spine and hip was performed before therapy and after 12 months. BMD, T score, and z score were assessed. Results : Fifteen patients received 2 doses of therapy and were fully reassessed after 1 year. At baseline and after 12 months, the absorptiometry revealed T scores of ?3.439 standard deviations (SD) vs ?2.33 SD at lumbar segment 2 (L2) and ?2.957 SD vs ?2.067 SD at lumbar segment 3 (L3), z scores of ?2.24 SD vs ?1.36 SD at L2 and ?1.995 vs ?1.067 SD at L3, and BMD of 0.801 vs 0.946 at L2 and 0.857 vs 0.979 at L3, respectively. Two serious outcomes were reported, without any correlation to the intervention. Two patients were weaned off HPN and hence discontinued. One patient experienced sciatica, resulting in discontinuation of the intervention. Conclusions : This study showed that denosumab may be a valuable treatment option for improving BMD in HPN patients.