HIVPhase 3ToV5NCT02305927
Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
A Phase 3 study testing Vitamin D3 (cholecalciferol) in people with HIV, run by Wafaie Fawzi at 1 site in Tanzania.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,300 participants
- Where
- 1 siteTanzania
- Study dates
- 15 Jun 2015to 18 Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Enrolled in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- HIV
- Being tested
- Vitamin D3 (cholecalciferol), Placebo
- Keywords
- Vitamin D, Pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboOther
Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (cholecalciferol) | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 (cholecalciferol) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants experiencing maternal HIV progression
Measured: Second Trimester until 12 months post partum
Proportion of small-for-gestational age infants
Measured: Birth
Proportion of stunted infants (height-for-age z-score < -2)
Measured: 12 months postpartum (1 year of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start15 Jun 2015
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wafaie Fawzi
- Sponsor type
- University, hospital or other
- Collaborators
- Management and Development for Health (MDH)
- Responsible party
- Sponsor-investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MBBS, DrPH, Principal investigator, Harvard School of Public Health (HSPH)Christopher R Sudfeld, ScD, Principal investigator, Harvard School of Public Health (HSPH)Karim P Manji, MD, Principal investigator, Management and Development for Health (MDH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305927
- Sponsor's protocol ID
- R01HD083113
- Acronym
- ToV5
- Status last verified
- Apr 2020
- First submitted
- 29 Oct 2014
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28870263Shobanke 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.
PubMed 41120170Lauer 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.
PubMed 39278411Sudfeld 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.
PubMed 35427363
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
- ClinicalTrials.gov ID
- NCT02305927
- Acronym / sponsor ID
- ToV5 / R01HD083113
- Conditions
- HIV
- Keywords
- Vitamin D, Pregnant women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Wafaie FawziUniversity, hospital or other
- Collaborators
- Management and Development for Health (MDH)
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (cholecalciferol) | Experimental | Dietary Supplement: Vitamin D3 (cholecalciferol) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Enrolled in any other clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (cholecalciferol)Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum | Dietary supplement | Vitamin D3 (cholecalciferol) |
| PlaceboPlacebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum | Other | Placebo |
Primary outcome
Proportion of participants experiencing maternal HIV progression
Time frame: Second Trimester until 12 months post partum
Proportion of small-for-gestational age infants
Time frame: Birth
Proportion of stunted infants (height-for-age z-score < -2)
Time frame: 12 months postpartum (1 year of age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Background: PubMed 28870263Sudfeld 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.
- Derived from this study: PubMed 41120170Shobanke 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.
- Derived from this study: PubMed 39278411Lauer 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.
- Derived from this study: PubMed 35427363Sudfeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaie W Fawzi, MBBS, DrPH principal investigator
Harvard School of Public Health (HSPH)
Christopher R Sudfeld, ScD principal investigator
Harvard School of Public Health (HSPH)
Karim P Manji, MD principal investigator
Management and Development for Health (MDH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 (cholecalciferol) in people with HIV, run by Wafaie Fawzi at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing maternal HIV progression (time frame: Second Trimester until 12 months post partum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305927, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.