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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.

BACKGROUND
Observational studies suggest that blood concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with morbidity, viral suppression, and mortality among adults living with HIV.


OBJECTIVE
We evaluated the effect of cholecalciferol (vitamin D3) supplementation on the risk of HIV disease progression, HIV-1 viral suppression, comorbidities, weight change, and depression among HIV-infected individuals that were initiating antiretroviral therapy (ART) in Dar es Salaam, Tanzania.


METHODS
We conducted a randomized, double-blind, placebo-controlled trial of vitamin D3 supplementation among 4,000 HIV-infected adult men and non-pregnant women initiating ART with insufficient serum 25(OH)D concentrations (<30 ng/mL). Participants were randomized to receive either weekly 50,000 IU doses for four weeks followed by daily 2,000 IU of vitamin D3 until 1-year or a matching placebo regimen given in weekly followed by daily doses until 1-year. Participants were followed-up at weekly visits for the first month followed by monthly visits thereafter. We conducted intention-to-treat analyses to assess the effect of vitamin D3 supplementation on the secondary trial outcomes of HIV progression or death, viral suppression, comorbidities, change in body mass index (BMI), >10% weight loss, incident wasting, and depression.


RESULTS
During follow-up, 345 participants (17.2%) in the vitamin D3 group and 371 participants (18.6%) in the placebo group experienced HIV disease progression or death and there was no difference in risk between groups (RR: 0.91, 95% CI: 0.79-1.06). Vitamin D3 supplementation did not affect the risk of an unsuppressed HIV-1 viral load (>1000 copies/mL) after 6 months (RR: 1.10, 95% CI: 0.87-1.41) and there was also no effect on change in BMI, risk of >10% weight loss, wasting, comorbidities and depression (p-values >0.05).


CONCLUSIONS
Vitamin D supplementation did not affect the risk of HIV progression, viral suppression, common morbidities, weight-related indicators, or depression among adults initiating ART in Tanzania. The trial was registered at clinicaltrial.gov as NCT01798680.