NCT01798680

Brief Summary

The purpose of this study is to determine the efficacy and safety of vitamin D3 (cholecalciferol) supplementation on HIV progression and incidence of pulmonary tuberculosis among HIV-positive Tanzanian adult men and women initiating highly active antiretroviral therapy (HAART).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

4.1 years

First QC Date

February 21, 2013

Last Update Submit

August 8, 2019

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (2)

  • All-cause death

    within 12 months after randomization

  • Pulmonary tuberculosis

    within 12 months after randomization

Secondary Outcomes (10)

  • CD4+ T-cell count

    6 and 12 months after randomization

  • Physician diagnosis of comorbidities

    within 12 months after randomization

  • Parathyroid hormone (PTH)

    1, 6, and 12 months after randomization

  • Alkaline phosphatase (ALP)

    1, 6, and 12 months after randomization

  • >10% weight loss

    monthly from month 1 to month 12

  • +5 more secondary outcomes

Study Arms (2)

Vitamin D3 (cholecalciferol)

EXPERIMENTAL
Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Vitamin D3 (cholecalciferol)DIETARY_SUPPLEMENT

Supplements containing 50,000 IU of vitamin D3 (cholecalciferol) taken orally once per week for 4 weeks (weeks 0, 1, 2, 3) followed by 2,000 IU of vitamin D3 (cholecalciferol) supplements taken orally once per day starting at 4 weeks until study discharge at 12 months

Vitamin D3 (cholecalciferol)
PlaceboOTHER

Placebo pills taken once weekly for 4 weeks (weeks 0, 1, 2, 3) followed by placebo pills taken orally once per day starting at 4 weeks until study discharge at 12 months

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-positive
  • Men or Women
  • Years of Age or older
  • Initiating HAART at time of randomization
  • (OH)D concentration \<30 ng/mL at HAART initiation

You may not qualify if:

  • Pregnant Women
  • Enrolled in another micronutrient trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Management and Development for Health (MDH)

Dar es Salaam, Tanzania

Location

Related Publications (3)

  • Sudfeld CR, Mugusi F, Aboud S, Nagu TJ, Wang M, Fawzi WW. 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 Feb 10;18(1):66. doi: 10.1186/s13063-017-1819-5.

    PMID: 28183335BACKGROUND

  • Muhihi A, Fawzi WW, Aboud S, Nagu TJ, Ulenga N, Wang M, Mugusi F, Sudfeld CR. 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. J Nutr. 2022 Aug 9;152(8):1983-1990. doi: 10.1093/jn/nxac096.

    PMID: 35460249DERIVED

  • Sudfeld CR, Mugusi F, Muhihi A, Aboud S, Nagu TJ, Ulenga N, Hong B, Wang M, Fawzi WW. Efficacy of vitamin D3 supplementation for the prevention of pulmonary tuberculosis and mortality in HIV: a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2020 Jul;7(7):e463-e471. doi: 10.1016/S2352-3018(20)30108-9.

    PMID: 32621874DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Wafaie W Fawzi, MBBS, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Ferdinand M Mugusi, MD

    Management and Development for Health (MDH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition, Epidemiology, and Global Health

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 26, 2013

Study Start

February 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 31, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

TA(1)