Clinical trial NCT02305927: Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
Official title: Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: Vitamin D
Pregnant women
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Management and Development for Health (MDH)
First posted: 2014-12-03
Enrollment: 2300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants experiencing maternal HIV progression
timeFrame: Second Trimester until 12 months post partum
measure: Proportion of small-for-gestational age infants
timeFrame: Birth
measure: Proportion of stunted infants (height-for-age z-score < -2)
timeFrame: 12 months postpartum (1 year of age)
Secondary outcomes:
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Management and Development for Health (MDH)
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MBBS, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Christopher R Sudfeld, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Management and Development for Health (MDH)
name: Karim P Manji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sudfeld CR, Manji KP, Duggan CP, Aboud S, Muhihi A, Sando DM, Al-Beity FMA, Wang M, Fawzi WW. 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. Trials. 2017 Sep 4;18(1):411. doi: 10.1186/s13063-017-2157-3.
citation: Sudfeld CR, Manji KP, Muhihi A, Duggan CP, Aboud S, Alwy Al-Beity FM, Wang M, Zhang N, Ulenga N, Fawzi WW. Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial. PLoS Med. 2022 Apr 15;19(4):e1003973. doi: 10.1371/journal.pmed.1003973. eCollection 2022 Apr.