Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Management and Development for Health (MDH) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Dietary Supplement | Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum |
| Measure | Description | 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wafaie W Fawzi, MBBS, DrPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Christopher R Sudfeld, ScD | Harvard School of Public Health (HSPH) | Principal Investigator |
| Karim P Manji, MD | Management and Development for Health (MDH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Management and Development for Health (MDH) | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28870263 | Background | 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. | |
| 41120170 | Derived | Shobanke T, Muhihi A, Perumal N, Ulenga N, Al-Beity FMA, Duggan CP, Fawzi WW, Manji KP, Sudfeld CR. Effect of vitamin D supplementation during pregnancy and lactation on the development of infants born to Tanzanian women living with HIV: a secondary analysis of a randomised controlled trial. BMJ Open. 2025 Oct 20;15(10):e098723. doi: 10.1136/bmjopen-2024-098723. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum |
|
| 39278411 | Derived | 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. 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. J Nutr. 2024 Nov;154(11):3400-3406. doi: 10.1016/j.tjnut.2024.08.032. Epub 2024 Sep 13. |
| 35427363 | Derived | 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. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |