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PregnancyPhase 2AViDD-2NCT01126528

Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial

A Phase 2 study testing Vitamin D3 in people with Pregnancy, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. Read more about this study

Who is it for?
Ages 18 to 34 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Vitamin D3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteBangladesh
Study dates
Aug 2010to May 2012
Phase
Phase 2
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 to 34 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women aged 18 to <35 years.
  • Current residence in Dhaka at a fixed address
  • Plans to have the delivery performed at the Shimantik maternity center, and to stay in Dhaka throughout the pregnancy and for at least one month past the date of delivery.
  • Gestational age of 26th to 29th (inclusive), estimated based on the first day of the last menstrual period (LMP).

Who cannot join

  • Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month prior to enrolment, or refusal to stop taking supplemental vitamin D at any dose after enrollment.
  • Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
  • Severe anemia (hemoglobin concentration < 70 g/L).
  • Complicated medical or obstetric history that may increase the risk of preterm birth or labor/delivery complications, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, preterm labor, or multiple gestation).
  • Prior history of delivery of an infant with a major congenital anomaly, birth asphyxia, or perinatal death (stillbirth or death within first week of life).

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • International Centre for Diarrheal Disease Research, Bangladesh (ICDDR,B)

    Dhaka, Dhaka Division

Other trials in Bangladesh

About this study

Official title: The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh

This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection.

The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function.

Read the detailed description

The primary aims of this study are:

AIM #1 - To assess the effect of weekly antenatal administration of oral vitamin D3 (875 mcg/week = 35,000 IU week ≈ 5,000 IU per day) started in the third trimester (26-29 weeks gestation) on maternal vitamin D status and fetal-neonatal vitamin D status (cord blood), in comparison to a placebo control supplement.

AIM #2 - To demonstrate the maternal and fetal safety of weekly maternal antenatal (second and third-trimester) vitamin D supplementation at a dose of 875 mcg/week by monitoring maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and newborn clinical parameters.

AIM #3 - To measure the effect of antenatal vitamin D supplementation on selected biomarkers of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear cell (CBMC) LL-37 expression, gene expression related to inflammatory and immunoregulatory pathways, Th1/Th2 cytokine secretion, and bactericidal properties.

Conditions
Pregnancy
Being tested
Vitamin D3, Placebo control
Keywords
Vitamin D, cholecalciferol, Micronutrients, Developing countries, Bangladesh, Infant, Newborn, Reproductive Health, Infant, Newborn, Diseases, Perinatology, Immunology, cathelicidin, Maternal Nutrition Physiology
Medical subject headings
Infant, Newborn, Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Dietary supplement

    Also called Cholecalciferol; Vigantol Oil

    35,000 IU per week, started at 26-29 weeks gestation, until delivery.

  • Placebo controlDietary supplement

    Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.

Study groups in NCT01126528
Study groupRoleWhat they receive
Vitamin D3ExperimentalVitamin D3 (cholecalciferol)
Receives: Dietary Supplement: Vitamin D3
ControlPlacebo comparatorPlacebo control group
Receives: Dietary Supplement: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum 25-hydroxyvitamin D concentration

    Biomarker of vitamin D status.

    Measured: Maternal: during 3rd trimester; Neonatal (cord blood)

Secondary outcomes (6)

  1. Serum calcium concentration

    Measured: Maternal:3rd trimester; Cord blood.

  2. Urine Ca:Cr ration

    Measured: Maternal- 3rd trimester

  3. Neonatal immune function

    Selected markers of innate and adaptive immunity.

    Measured: Cord blood

  4. Infant growth

    Infant growth parameters during postnatal follow-up, up to 12 months of age

    Measured: Postnatal observational follow-up phase

  5. Infant and maternal postnatal vitamin D status

    Measured: Postnatal observational follow-up phase

  6. Neonatal serum calcium

    Infant serum calcium during the first week postnatal.

    Measured: 1st week postnatal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2011
  4. Study completionMay 2012

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126528
Sponsor's protocol ID
JHU-IRB2481
Other IDs
02829-5
Acronym
AViDD-2
Status last verified
Aug 2012
First submitted
18 May 2010
Last updated
17 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

    PubMed 39077939

  • Akhtar E, Mily A, Haq A, Al-Mahmud A, El-Arifeen S, Hel Baqui A, Roth DE, Raqib R. Prenatal high-dose vitamin D3 supplementation has balanced effects on cord blood Th1 and Th2 responses. Nutr J. 2016 Aug 9;15(1):75. doi: 10.1186/s12937-016-0194-5.

    PubMed 27506771

  • Harrington J, Perumal N, Al Mahmud A, Baqui A, Roth DE. Vitamin D and fetal-neonatal calcium homeostasis: findings from a randomized controlled trial of high-dose antenatal vitamin D supplementation. Pediatr Res. 2014 Sep;76(3):302-9. doi: 10.1038/pr.2014.83. Epub 2014 Jun 17.

    PubMed 24937546

  • Roth DE, Perumal N, Al Mahmud A, Baqui AH. Maternal vitamin D3 supplementation during the third trimester of pregnancy: effects on infant growth in a longitudinal follow-up study in Bangladesh. J Pediatr. 2013 Dec;163(6):1605-1611.e3. doi: 10.1016/j.jpeds.2013.07.030. Epub 2013 Aug 30.

    PubMed 23998516

  • Roth DE, Al Mahmud A, Raqib R, Akhtar E, Perumal N, Pezzack B, Baqui AH. Randomized placebo-controlled trial of high-dose prenatal third-trimester vitamin D3 supplementation in Bangladesh: the AViDD trial. Nutr J. 2013 Apr 12;12:47. doi: 10.1186/1475-2891-12-47.

    PubMed 23587190

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D3 in people with Pregnancy, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

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 4 inclusion and 5 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 17 Aug 2012. 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 Bangladesh. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Serum 25-hydroxyvitamin D concentration (time frame: Maternal: during 3rd trimester; Neonatal (cord blood)). 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 NCT01126528, which also lists 5 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 17 Aug 2012.

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