scholarly journals Vitamin D for the Immune System in Cystic Fibrosis (DISC): a double-blind, multicenter, randomized, placebo-controlled clinical trial

2019 ◽  
Vol 109 (3) ◽  
pp. 544-553 ◽  
Author(s):  
Vin Tangpricha ◽  
Joshua Lukemire ◽  
Yuqing Chen ◽  
José Nilo G Binongo ◽  
Suzanne E Judd ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Vitamin D ◽  
Lung Function ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Pulmonary Exacerbation ◽  
Double Blind ◽  
Increased Risk ◽  
Pulmonary Exacerbations

ABSTRACT Background Patients with cystic fibrosis (CF) have increased risk of vitamin D deficiency owing to fat malabsorption and other factors. Vitamin D deficiency has been associated with increased risk of pulmonary exacerbations of CF. Objectives The primary objective of this study was to examine the impact of a single high-dose bolus of vitamin D3 followed by maintenance treatment given to adults with CF during an acute pulmonary exacerbation on future recurrence of pulmonary exacerbations. Methods This was a multicenter, double-blind, placebo-controlled, intent-to-treat clinical trial. Subjects with CF were randomly assigned to oral vitamin D3 given as a single dose of 250,000 International Units (IU) or to placebo within 72 h of hospital admission for an acute pulmonary exacerbation, followed by 50,000 IU of vitamin D3 or an identically matched placebo pill taken orally every other week starting at 3 mo after random assignment. The primary outcome was the composite endpoint of the time to next pulmonary exacerbation or death within 1 y. The secondary outcomes included circulating concentrations of the antimicrobial peptide cathelicidin and recovery of lung function as assessed by the percentage of predicted forced expiratory volume in 1 s (FEV1%). Results A total of 91 subjects were enrolled in the study. There were no differences between the vitamin D3 and placebo groups in time to next pulmonary exacerbation or death at 1 y. In addition, there were no differences in serial recovery of lung function after pulmonary exacerbation by FEV1% or in serial concentrations of plasma cathelicidin. Conclusions Vitamin D3 initially given at the time of pulmonary exacerbation of CF did not alter the time to the next pulmonary exacerbation, 12-mo mortality, serial lung function, or serial plasma cathelicidin concentrations. This trial was registered at clinicaltrials.gov as NCT01426256.

The effect of supplementation of vitamin D in neurocritical care patients: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY)

2020 ◽  
Vol 133 (4) ◽  
pp. 1103-1112 ◽  
Author(s):  
Michael Karsy ◽  
Jian Guan ◽  
Ilyas Eli ◽  
Andrea A. Brock ◽  
Sarah T. Menacho ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Clinical Trial ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Neurocritical Care ◽  
Hypovitaminosis D ◽  
Mean Difference ◽  
Saps Ii ◽  
Gcs Score

OBJECTIVEHypovitaminosis D is prevalent in neurocritical care patients, but the potential to improve patient outcome by replenishing vitamin D has not been investigated. This single-center, double-blinded, placebo-controlled, randomized (1:1) clinical trial was designed to assess the effect on patient outcome of vitamin D supplementation in neurocritical care patients with hypovitaminosis D.METHODSFrom October 2016 until April 2018, emergently admitted neurocritical care patients with vitamin D deficiency (≤ 20 ng/ml) were randomized to receive vitamin D3 (cholecalciferol, 540,000 IU) (n = 134) or placebo (n = 133). Hospital length of stay (LOS) was the primary outcome; secondary outcomes included intensive care unit (ICU) LOS, repeat vitamin D levels, patient complications, and patient disposition. Exploratory analysis evaluated specific subgroups of patients by LOS, Glasgow Coma Scale (GCS) score, and Simplified Acute Physiology Score (SAPS II).RESULTSTwo-hundred seventy-four patients were randomized (intent-to-treat) and 267 were administered treatment within 48 hours of admission (as-treated; 61.2% of planned recruitment) and monitored. The mean age of as-treated patients was 54.0 ± 17.2 years (56.9% male, 77.2% white). After interim analysis suggested a low conditional power for outcome difference (predictive power 0.12), the trial was halted. For as-treated patients, no significant difference in hospital LOS (10.4 ± 14.5 days vs 9.1 ± 7.9 days, p = 0.4; mean difference 1.3, 95% CI −1.5 to 4.1) or ICU LOS (5.8 ± 7.5 days vs 5.4 ± 6.4 days, p = 0.4; mean difference 0.4, 95% CI −1.3 to 2.1) was seen between vitamin D3 and placebo groups, respectively. Vitamin D3 supplementation significantly improved repeat serum levels compared with placebo (20.8 ± 9.3 ng/ml vs 12.8 ± 4.8 ng/ml, p < 0.001) without adverse side effects. No subgroups were identified by exclusion of LOS outliers or segregation by GCS score, SAPS II, or severe vitamin D deficiency (≤ 10 ng/ml).CONCLUSIONSDespite studies showing that vitamin D can predict prognosis, supplementation in vitamin D–deficient neurocritical care patients did not result in appreciable improvement in outcomes and likely does not play a role in acute clinical recovery.Clinical trial registration no.: NCT02881957 (clinicaltrials.gov)

scholarly journals Effects of a 2-Week 5000 IU versus 1000 IU Vitamin D3 Supplementation on Recovery of Symptoms in Patients with Mild to Moderate Covid-19: A Randomized Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2170
Author(s):  
Shaun Sabico ◽  
Mushira A. Enani ◽  
Eman Sheshah ◽  
Naji J. Aljohani ◽  
Dara A. Aldisi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Randomized Clinical Trial ◽  
Vitamin D3 ◽  
Sensory Loss ◽  
Vitamin D Status ◽  
Oral Vitamin ◽  
Increased Risk ◽  
Vitamin D3 Supplementation ◽  
Group Comparisons

Objective: Vitamin D deficiency has been associated with an increased risk of COVID-19 severity. This multi-center randomized clinical trial aims to determine the effects of 5000 IU versus 1000 IU daily oral vitamin D3 supplementation in the recovery of symptoms and other clinical parameters among mild to moderate COVID-19 patients with sub-optimal vitamin D status. Study Design and Setting: A total of 69 reverse transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 positive adults who were hospitalized for mild to moderate COVID-19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 (n = 36, 21 males; 15 females) or 1000 IU oral vitamin D3 (standard control) (n = 33, 13 males; 20 females). Anthropometrics were measured and blood samples were taken pre- and post-supplementation. Fasting blood glucose, lipids, serum 25(OH)D, and inflammatory markers were measured. COVID-19 symptoms were noted on admission and monitored until full recovery. Results: Vitamin D supplementation for 2 weeks caused a significant increase in serum 25(OH)D levels in the 5000 IU group only (adjusted p = 0.003). Within-group comparisons also showed a significant decrease in BMI and IL-6 levels overtime in both groups (p-values < 0.05) but was not clinically significant in between-group comparisons. Kaplan–Meier survival analysis revealed that the 5000 IU group had a significantly shorter time to recovery (days) than the 1000 IU group in resolving cough, even after adjusting for age, sex, baseline BMI, and D-dimer (6.2 ± 0.8 versus 9.1 ± 0.8; p = 0.039), and ageusia (loss of taste) (11.4 ± 1.0 versus 16.9 ± 1.7; p = 0.035). Conclusion: A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.

25-OHD response to vitamin D supplementation in children: effect of dose but not GC haplotype

2021 ◽  
Author(s):  
Christine A. Simpson ◽  
Jane H. Zhang ◽  
Dirk Vanderschueren ◽  
Lei Fu ◽  
Teresita C. Pennestri ◽  
...  
Keyword(s):  
At Risk ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Randomized Study ◽  
Vitamin D Supplementation ◽  
Children At Risk ◽  
Double Blind ◽  
Baseline Levels ◽  
To Receive

Objective: GC/DBP effects on response to vitamin D supplementation have not been well-studied. Thus we assessed free and total 25-OHD after vitamin D treatment across the 6 common GC haplotypes. Design: This double-blind, randomized study compared two vitamin D3 doses in healthy, urban-dwelling 6-month to 10-year-old children at-risk for vitamin D deficiency. Randomization was stratified by GC haplotype. Methods: Children were randomized to receive 2800 or 7000 International Units of vitamin D3 weekly. 25-OHD and 1,25(OH)2D were sampled at baseline and after 1 and 6 months of supplementation. Results and Conclusions: 192 of 225 enrolled subjects completed the study. After one month, total 25-OHD increased with both doses, and were higher with 7000 IU/week (85.5 ± 22.8 nmol/L) compared to 2800 IU/week (76.8 ± 18.0 nmol/L), despite equivalent baseline levels. No further significant increase occurred at 6 months (89.8 ± 35.5 and 74.3 ± 18.3 nmol/L, respectively). Free 25-OHD similarly changed. 25-OHD differed among GC groups at baseline. Although no significant effects of individual GC haplotypes on incremental changes were evident, a trend towards an effect of combined “at risk” GC alleles on response was evident (P=0.06). Total 1,25(OH)2D showed modest increases, moreso with the larger dose. In urban-dwelling children at-risk for vitamin D deficiency, one month of vitamin D3 2800 IU/week increased 25-OHD across all GC haplotype groups, and somewhat enhanced with 7000 IU/week with no further significant increases after 6 months of supplementation. Free 25-OHD measures offer no monitoring advantage over total 25-OHD.

Effect of Vitamin D Therapy on Sexual Function in Women with Sexual Dysfunction and Vitamin D Deficiency: A Randomized, Double-Blind, Placebo Controlled Clinical Trial

2019 ◽  
Vol 201 (5) ◽  
pp. 987-993 ◽  
Author(s):  
Fatemeh Jalali-Chimeh ◽  
Ali Gholamrezaei ◽  
Mohammadreza Vafa ◽  
Malihe Nasiri ◽  
Behnaz Abiri ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Sexual Dysfunction ◽  
Sexual Function ◽  
Vitamin D Deficiency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Single high-dose oral vitamin D3 (stoss) therapy — A solution to vitamin D deficiency in children with cystic fibrosis?

2013 ◽  
Vol 12 (2) ◽  
pp. 177-182 ◽  
Author(s):  
Darren Shepherd ◽  
Yvonne Belessis ◽  
Tamarah Katz ◽  
John Morton ◽  
Penny Field ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
High Dose ◽  
Oral Vitamin ◽  
Single High Dose ◽  
Dose Oral
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