NCT02305927: ToV5

Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health

Completed Phase 3 Last updated 24 April 2020

What this trial tests

Phase 3 trial testing Vitamin D3 (cholecalciferol) in HIV in 2,300 participants. Completed in 18 September 2019.

Timeline

15 June 2015

Primary endpoint
18 September 2019

18 September 2019

Quick facts

Lead sponsor	Wafaie Fawzi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	2,300
Start date	15 June 2015
Primary completion	18 September 2019
Estimated completion	18 September 2019
Sites	1 location across Tanzania

Drugs / interventions tested

• Vitamin D3 (cholecalciferol)
• Placebo

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Wafaie Fawzi

Who can join

18 and older, female only, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol) supplementation on maternal HIV progression, small-for-gestational age infants, and infant stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving highly active antiretroviral therapy (HAART).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitamin D supplementation during pregnancy: state of the evidence from a systematic review of randomised trials.
   Roth DE, Leung M, Mesfin E, Qamar H, et al · · 2017 · cited 151× · PMID 29187358 · DOI 10.1136/bmj.j5237
2. 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.
   Sudfeld CR, Mugusi F, Aboud S, Nagu TJ, et al · · 2017 · cited 19× · PMID 28183335 · DOI 10.1186/s13063-017-1819-5
3. Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial.
   Sudfeld CR, Manji KP, Muhihi A, Duggan CP, et al · · 2022 · cited 18× · PMID 35427363 · DOI 10.1371/journal.pmed.1003973
4. Effect of maternal vitamin D₃ supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial.
   Sudfeld CR, Manji KP, Duggan CP, Aboud S, et al · · 2017 · cited 15× · PMID 28870263 · DOI 10.1186/s13063-017-2157-3
5. Biomarkers of environmental enteric dysfunction and adverse birth outcomes: An observational study among pregnant women living with HIV in Tanzania.
   Kirby MA, Lauer JM, Muhihi A, Ulenga N, et al · · 2022 · cited 14× · PMID 36130475 · DOI 10.1016/j.ebiom.2022.104257
6. Assessing environmental enteric dysfunction via multiplex assay and its relation to growth and development among HIV-exposed uninfected Tanzanian infants.
   Lauer JM, Kirby MA, Muhihi A, Ulenga N, et al · · 2023 · cited 6× · PMID 36943785 · DOI 10.1371/journal.pntd.0011181
7. Associations Between Social Support and Symptoms of Antenatal Depression with Infant Growth and Development Among Mothers Living with HIV in Tanzania.
   Saleh A, Perumal N, Muhihi A, Duggan CP, et al · · 2023 · cited 5× · PMID 37140717 · DOI 10.1007/s10461-023-04073-5
8. Third Trimester Vitamin D Status Is Associated With Birth Outcomes and Linear Growth of HIV-Exposed Uninfected Infants in the United States.
   Sudfeld CR, Jacobson DL, Rueda NM, Neri D, et al · · 2019 · cited 5× · PMID 31021992 · DOI 10.1097/qai.0000000000002041