Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health (ToV5)

Wafaie Fawzi

Status and phase: Completed; Phase 3

Conditions: HIV

Treatments: Dietary Supplement: Vitamin D3 (cholecalciferol); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02305927

R01HD083113

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,300 participants in 2 patient groups, including a placebo group

Vitamin D3 (cholecalciferol)

Experimental group

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo

Placebo Comparator group

Treatment:

Other: Placebo