NCT02305927

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for phase_3 hiv

Timeline
Completed

Started Jun 2015

Typical duration for phase_3 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 15, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4.3 years

First QC Date

October 29, 2014

Last Update Submit

April 22, 2020

Conditions

HIV

Keywords

Vitamin DPregnant women

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

Vitamin D3 (cholecalciferol)

EXPERIMENTAL
Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

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

Vitamin D3 (cholecalciferol)
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Enrolled in any other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Management and Development for Health (MDH)

Dar es Salaam, Tanzania

Location

Related Publications (4)

  • 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.

    PMID: 28870263BACKGROUND

  • 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.

    PMID: 41120170DERIVED

  • 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.

    PMID: 39278411DERIVED

  • 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.

    PMID: 35427363DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Nutrition, Epidemiology, and Global Health

Study Record Dates

First Submitted

October 29, 2014

First Posted

December 3, 2014

Study Start

June 15, 2015

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

TA(1)