In order to meet these goals we are proposing a "gold standard" investigation with a randomized, double-blind, placebo-controlled trial. Briefly, we wil enroll 4000 adult men and non-pregnant women who are starting ART within the Management and Development for Health (MDH) President's Emergency Plan for AIDS Relief (PEPFAR) treatment program in Dar-es-Salaam, Tanzania. Individuals who consent for enrollment in the trial will be randomized to receive an oral supplement regimen of one of two groups: (a) vitamin D3 oral supplements containing 50,000 IU taken weekly at clinic visits for 4 weeks (weeks 0, 1, 2, 3) followed by maintenance 2,000 IU oral supplements taken daily at home for the remaining trial duration (week 4 and continued through 1 year) or (b) placebo supplements taken weekly at clinic visits for 4 weeks (weeks 0, 1, 2, 3) followed by placebo oral supplements taken daily at home for the remaining trial duration (week 4 and continued through 1 year). We will then follow study participants for 1 year at monthly clinic and home visits to assess our two primary trial endpoints: (a) death and (b) incident pulmonary tuberculosis. Secondarily, we will also assess the effect of vitamin D3 on (i) CD4 T-cell counts, (ii) incidence of comorbidities and complications associated with HIV and/or ART, (iii) markers of bone health in blood, and (iv) weight gain. Evidence from this randomized trial is urgently needed since ART coverage is rapidly expanding globally and treatment programs are in need of interventions to prolong and improve the quality of life for HIV-infected individuals initiating ART during the first months of treatment.

Public Health Relevance

HIV-infected individuals initiating antiretroviral therapy in sub-Saharan Africa experience very high mortality rates during the first year of HIV treatment. This randomized trial may provide evidence that vitamin D3 supplements prolong and improve the quality of life for these individuals, which may result in adding these supplements to standard HIV care.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
1R01DK098075-01A1
Application #
8542268
Study Section
AIDS Clinical Studies and Epidemiology Study Section (ACE)
Program Officer
Malozowski, Saul N
Project Start
2013-04-01
Project End
2018-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
1
Fiscal Year
2013
Total Cost
$540,325
Indirect Cost
$93,458
Name
Harvard University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02115