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Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial.

Abstract

BACKGROUND

HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in high-income and resource-limited settings indicate that HIV-infected adults with low vitamin D levels may be at increased risk of mortality, HIV disease progression, and incidence of pulmonary tuberculosis (TB). As a result, vitamin D3 supplementation may improve survival and treatment outcomes for HIV-infected adults initiating ART.

METHODS/DESIGN

The Trial of Vitamins-4 (ToV4) is an individually randomized, double-blind, placebo-controlled trial of vitamin D3 (cholecalciferol) supplementation conducted among 4000 HIV-infected adults with low vitamin D levels [25-hydroxyvitamin D (25(OH)D) <30 ng/mL] initiating ART in Dar es Salaam, Tanzania. The two primary aims of the trial are to determine the effect of a vitamin D3 supplementation regimen on incidence of (1) mortality and (2) pulmonary TB as compared to a matching placebo regimen. The primary safety outcome of the study is incident hypercalcemia. The investigational vitamin D3 regimen consists of oral supplements containing 50,000 IU vitamin D3 taken under direct observation at randomization and once a week for 3 weeks (four doses) followed by daily oral supplements containing 2000 IU vitamin D3 taken at home from the fourth week until trial discharge at 1 year post ART initiation. Trial participants are followed up at weekly clinic visits during the first month of ART and at monthly clinic visits thereafter until trial discharge at 1 year post ART initiation. Secondary aims of the trial are to examine the effect of the vitamin D3 regimen on CD4 T cell reconstitution, incidence of non-TB comorbidities, body mass index (BMI), depression and anxiety, physical activity, bone health, and immunologic biomarkers.

DISCUSSION

The ToV4 will provide causal evidence on the effect of vitamin D3 supplementation on incidence of pulmonary TB and mortality among HIV-infected Tanzanian adults initiating ART. The trial will also give insight to whether vitamin D3 supplementation trials for the prevention of pulmonary TB should be pursued in HIV-uninfected populations.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT01798680 . Registered on 21 February 2013.

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  • Authors+Show Affiliations

    ,

    Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Ave, Building I Room 1104C, Boston, MA, 02115, USA. csudfeld@hsph.harvard.edu.

    ,

    Management and Development for Health, Dar es Salaam, Tanzania. Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

    ,

    Management and Development for Health, Dar es Salaam, Tanzania. Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

    ,

    Management and Development for Health, Dar es Salaam, Tanzania. Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

    ,

    Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.

    Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Ave, Building I Room 1104C, Boston, MA, 02115, USA. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.

    Source

    Trials 18:1 2017 02 10 pg 66

    MeSH

    AIDS-Related Opportunistic Infections
    Administration, Oral
    Anti-Retroviral Agents
    Cholecalciferol
    Clinical Protocols
    Coinfection
    Dietary Supplements
    Double-Blind Method
    Drug Administration Schedule
    HIV Infections
    Humans
    Immunocompromised Host
    Incidence
    Nutritional Status
    Protective Factors
    Research Design
    Risk Assessment
    Risk Factors
    Tanzania
    Time Factors
    Treatment Outcome
    Tuberculosis, Pulmonary
    Vitamin D Deficiency

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    28183335

    Citation

    Sudfeld, Christopher R., et al. "Efficacy of Vitamin D3 Supplementation in Reducing Incidence of Pulmonary Tuberculosis and Mortality Among HIV-infected Tanzanian Adults Initiating Antiretroviral Therapy: Study Protocol for a Randomized Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 66.
    Sudfeld CR, Mugusi F, Aboud S, et al. Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial. Trials. 2017;18(1):66.
    Sudfeld, C. R., Mugusi, F., Aboud, S., Nagu, T. J., Wang, M., & Fawzi, W. W. (2017). Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial. Trials, 18(1), p. 66. doi:10.1186/s13063-017-1819-5.
    Sudfeld CR, et al. Efficacy of Vitamin D3 Supplementation in Reducing Incidence of Pulmonary Tuberculosis and Mortality Among HIV-infected Tanzanian Adults Initiating Antiretroviral Therapy: Study Protocol for a Randomized Controlled Trial. Trials. 2017 02 10;18(1):66. PubMed PMID: 28183335.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial. AU - Sudfeld,Christopher R, AU - Mugusi,Ferdinand, AU - Aboud,Said, AU - Nagu,Tumaini J, AU - Wang,Molin, AU - Fawzi,Wafaie W, Y1 - 2017/02/10/ PY - 2016/04/04/received PY - 2017/01/26/accepted PY - 2017/2/11/entrez PY - 2017/2/12/pubmed PY - 2018/3/6/medline KW - Cholecalciferol KW - HIV KW - Micronutrient KW - Nutrition KW - Tanzania KW - Tuberculosis KW - Vitamin D SP - 66 EP - 66 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in high-income and resource-limited settings indicate that HIV-infected adults with low vitamin D levels may be at increased risk of mortality, HIV disease progression, and incidence of pulmonary tuberculosis (TB). As a result, vitamin D3 supplementation may improve survival and treatment outcomes for HIV-infected adults initiating ART. METHODS/DESIGN: The Trial of Vitamins-4 (ToV4) is an individually randomized, double-blind, placebo-controlled trial of vitamin D3 (cholecalciferol) supplementation conducted among 4000 HIV-infected adults with low vitamin D levels [25-hydroxyvitamin D (25(OH)D) <30 ng/mL] initiating ART in Dar es Salaam, Tanzania. The two primary aims of the trial are to determine the effect of a vitamin D3 supplementation regimen on incidence of (1) mortality and (2) pulmonary TB as compared to a matching placebo regimen. The primary safety outcome of the study is incident hypercalcemia. The investigational vitamin D3 regimen consists of oral supplements containing 50,000 IU vitamin D3 taken under direct observation at randomization and once a week for 3 weeks (four doses) followed by daily oral supplements containing 2000 IU vitamin D3 taken at home from the fourth week until trial discharge at 1 year post ART initiation. Trial participants are followed up at weekly clinic visits during the first month of ART and at monthly clinic visits thereafter until trial discharge at 1 year post ART initiation. Secondary aims of the trial are to examine the effect of the vitamin D3 regimen on CD4 T cell reconstitution, incidence of non-TB comorbidities, body mass index (BMI), depression and anxiety, physical activity, bone health, and immunologic biomarkers. DISCUSSION: The ToV4 will provide causal evidence on the effect of vitamin D3 supplementation on incidence of pulmonary TB and mortality among HIV-infected Tanzanian adults initiating ART. The trial will also give insight to whether vitamin D3 supplementation trials for the prevention of pulmonary TB should be pursued in HIV-uninfected populations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01798680 . Registered on 21 February 2013. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28183335/Efficacy_of_vitamin_D3_supplementation_in_reducing_incidence_of_pulmonary_tuberculosis_and_mortality_among_HIV_infected_Tanzanian_adults_initiating_antiretroviral_therapy:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1819-5 DB - PRIME DP - Unbound Medicine ER -