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

Conditions

HIV

Keywords

Vitamin D, Pregnant women

Brief summary

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).

Detailed description

The study is a randomized, double-blind, placebo-controlled trial of maternal vitamin D3 (cholecalciferol) supplementation starting in the second trimester (12-27 weeks gestation) and continuing until 12 months postpartum among HIV-infected Tanzanian pregnant women who are receiving HAART. Eligible individuals are randomized to receive a) a vitamin D3 regimen consisting 3,000 IU of vitamin D3 taken orally once daily starting in the second trimester and continuing until 12 months postpartum or b) a placebo regimen taken orally once daily starting in the second trimester and continuing until 12 months postpartum. Mothers will be followed at study visits during pregnancy and mother/infant pairs will attend study visits from birth until trial discharge at 12 months postpartum.

Shobanke T, Muhihi A, Perumal N, Ulenga N, Al-Beity FMA, Duggan CP, Fawzi WW, Manji KP, Sudfeld CR.

2025-10-20

10.1136/bmjopen-2024-098723

Effects of Vitamin D-3 Supplementation During Pregnancy and Lactation on Maternal and Infant Biomarkers of Environmental Enteric Dysfunction, Systemic Inflammation, and Growth: A Secondary Analysis of a Randomized Controlled Trial.

Lauer JM, Kirby MA, Muhihi A, Ulenga N, Aboud S, Liu E, Choy RK, Arndt MB, Kou J, Fawzi WW, Gewirtz AT, Sudfeld CR, Manji KP, Duggan CP.

2024-09-13

10.1016/j.tjnut.2024.08.032

Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial

Christopher R. Sudfeld, Karim Manji, Alfa Muhihi, Christopher Duggan, Said Aboud et al. (10 authors)

PLoS Medicine2022-04-1519 citations

10.1371/journal.pmed.1003973

Effect of maternal vitamin D<sub>3</sub> 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, Muhihi A, Sando DM, Al-Beity FMA, Wang M, Fawzi WW.

2017-09-0415 citations

10.1186/s13063-017-2157-3

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

Christopher R. Sudfeld, Ferdinand Mugusi, Said Aboud, Tumaini Nagu, Molin Wang et al. (6 authors)

Trials2017-02-1025 citations

10.1186/s13063-017-1819-5

Interventions

DIETARY_SUPPLEMENTVitamin D3 (cholecalciferol)

Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum

OTHERPlacebo

Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Women aged ≥18 years old * HIV-positive * Receiving HAART * Pregnant and of 12-27 weeks gestation (Second Trimester) * Calcium levels in the normal physiologic range (≤2.6 mmol/L)

Exclusion criteria

* Enrolled in any other clinical trial

Design outcomes

Primary

Measure	Time frame
Proportion of participants experiencing maternal HIV progression	Second Trimester until 12 months post partum
Proportion of small-for-gestational age infants	Birth
Proportion of stunted infants (height-for-age z-score < -2)	12 months postpartum (1 year of age)

Countries

Tanzania

Outcome results

None listed