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High-dose vitamin D3 supplementation in children and young adults with HIV: a randomized, placebo-controlled trial.
Pediatr Infect Dis J 2015; 34(2):e32-40PI

Abstract

BACKGROUND

Suboptimal 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.

METHODS

This 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.

RESULTS

Fifty-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).

CONCLUSIONS

Daily 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.

Authors+Show Affiliations

From the *Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia; †Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania; ‡Allergy and Immunology; and §General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24988118

Citation

Stallings, Virginia A., et al. "High-dose Vitamin D3 Supplementation in Children and Young Adults With HIV: a Randomized, Placebo-controlled Trial." The Pediatric Infectious Disease Journal, vol. 34, no. 2, 2015, pp. e32-40.
Stallings VA, Schall JI, Hediger ML, et al. High-dose vitamin D3 supplementation in children and young adults with HIV: a randomized, placebo-controlled trial. Pediatr Infect Dis J. 2015;34(2):e32-40.
Stallings, V. A., Schall, J. I., Hediger, M. L., Zemel, B. S., Tuluc, F., Dougherty, K. A., ... Rutstein, R. M. (2015). High-dose vitamin D3 supplementation in children and young adults with HIV: a randomized, placebo-controlled trial. The Pediatric Infectious Disease Journal, 34(2), pp. e32-40. doi:10.1097/INF.0000000000000483.
Stallings VA, et al. High-dose Vitamin D3 Supplementation in Children and Young Adults With HIV: a Randomized, Placebo-controlled Trial. Pediatr Infect Dis J. 2015;34(2):e32-40. PubMed PMID: 24988118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-dose vitamin D3 supplementation in children and young adults with HIV: a randomized, placebo-controlled trial. AU - Stallings,Virginia A, AU - Schall,Joan I, AU - Hediger,Mary L, AU - Zemel,Babette S, AU - Tuluc,Florin, AU - Dougherty,Kelly A, AU - Samuel,Julia L, AU - Rutstein,Richard M, PY - 2014/7/3/entrez PY - 2014/7/6/pubmed PY - 2015/11/14/medline SP - e32 EP - 40 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 34 IS - 2 N2 - BACKGROUND: Suboptimal 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. METHODS: This 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. RESULTS: Fifty-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). CONCLUSIONS: Daily 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. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/24988118/High_dose_vitamin_D3_supplementation_in_children_and_young_adults_with_HIV:_a_randomized_placebo_controlled_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=24988118 DB - PRIME DP - Unbound Medicine ER -