Trial reportThe Pediatric infectious disease journal2015
High-dose vitamin D3 supplementation in children and young adults with HIV: a randomized, placebo-controlled trial.
Trial report in The Pediatric infectious disease journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02965898 (The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Pooled it
- Micronutrient supplementation in adults with HIV infection.The Cochrane database of systematic reviews · 2017Pooled it
- Vitamin D supplementation for preventing infections in children under five years of age.The Cochrane database of systematic reviews · 2016Pooled it
- Cholecalciferol Supplementation Does Not Affect the Risk of HIV Progression, Viral Suppression, Comorbidities, Weight Loss, and Depression among Tanzanian Adults Initiating Antiretroviral Therapy: Secondary Outcomes of a Randomized Trial.The Journal of nutrition · 2022Trial
- Trial
- Effects of vitamin D supplementation on carotid intima-media thickness in HIV-infected youth.Virulence · 2018Trial
- Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth.Antiviral therapy · 2018Trial
- Effects of cholecalciferol supplementation on serum and urinary vitamin D metabolites and binding protein in HIV-infected youth.The Journal of steroid biochemistry and molecular biology · 2017Trial
- Effect of high-dose cholecalciferol (vitamin DOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017Trial
- The impact of vitamin D3 supplementation on muscle function among HIV-infected children and young adults: a randomized controlled trial.Journal of musculoskeletal & neuronal interactions · 2015Trial
- Efficacy of vitamin D supplementation among persons living with HIV/AIDS in São Paulo city, Brazil.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesTrial
- Vitamin D Imbalance and Hydro-Electrolyte Disturbances in Hospitalized Children: A Comparation Between Post-COVID-19 Status and SARS-CoV-2/EBV Coinfection.Biomedicines · 2025Article
- Vitamin D Decreases Susceptibility of CD4Biomolecules · 2025Article
- Review
- Effect of high dose vitamin DJournal of virus eradication · 2023Article
- An Update on the Effects of Vitamin D on the Immune System and Autoimmune Diseases.International journal of molecular sciences · 2022Review
- Vitamin D can reduce severity in COVID-19 through regulation of PD-L1.Naunyn-Schmiedeberg's archives of pharmacology · 2022Review
- The Role of Vitamin D Supplementation in Children with Autism Spectrum Disorder: A Narrative Review.Nutrients · 2021Review
- Vitamin D and Rheumatic Diseases: A Review of Clinical Evidence.International journal of molecular sciences · 2021Review
- Micronutrients in Sepsis and COVID-19: A Narrative Review on What We Have Learned and What We Want to Know in Future Trials.Medicina (Kaunas, Lithuania) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundSuboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity. We aimed to determine 12-month safety and efficacy of daily 7000 IU vitamin D3 (vitD3) versus placebo to sustain increased serum 25-hydroxyvitamin D (25(OH)D) and improve immune status in HIV-infected subjects.
methodsThis was a double-blind trial of perinatally acquired HIV (PHIV)-infected subjects or behaviorally acquired HIV (BHIV)-infected subjects (5.0-24.9 years). Safety, 25(OH)D-related parameters and immune status were assessed at baseline, 3, 6 and 12 months.
resultsFifty-eight subjects enrolled (67% male, 85% African American and 64% BHIV) and 50 completed with no safety concerns. In unadjusted analyses, there were no differences between randomization groups at baseline; at 3, 6 and 12 months, 25(OH)D was higher with supplementation than baseline and higher than with placebo (P < 0.05). In adjusted mixed models, in the supplementation group, the fixed effect of 25(OH)D was higher (P < 0.001). Percentage of naive T-helper cells (Th naive%) were significantly (P < 0.01) and T-helper cells (CD4%) marginally (P < 0.10) increased with supplementation in those taking highly active antiretroviral therapy (HAART), and RNA viral load was reduced (P ≤ 0.05). In exploratory linear models, change in 25(OH)D predicted RNA viral load at 3 and 12 months and CD4% at 3 months (P < 0.05).
conclusionsDaily 7000 IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25(OH)D. Supplementation improved some clinically important HIV immune markers in subjects on HAART. Adjunct therapy with high-dose, daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.