HIV Clinical Trial
— ToV5Official title:
Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
Verified date | April 2020 |
Source | Harvard School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 2300 |
Est. completion date | September 18, 2019 |
Est. primary completion date | September 18, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Management and Development for Health (MDH) | Dar es Salaam |
Lead Sponsor | Collaborator |
---|---|
Wafaie Fawzi | Management and Development for Health (MDH) |
Tanzania,
Sudfeld CR, Manji KP, Duggan CP, Aboud S, Muhihi A, Sando DM, Al-Beity FMA, Wang M, Fawzi WW. Effect of maternal vitamin D(3) 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants experiencing maternal HIV progression | Second Trimester until 12 months post partum | ||
Primary | Proportion of small-for-gestational age infants | Birth | ||
Primary | Proportion of stunted infants (height-for-age z-score < -2) | 12 months postpartum (1 year of age) |
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