AzTrials
AzTrials

PregnancyPhase 3MDIGNCT01924013

Maternal Vitamin D for Infant Growth (MDIG) Trial

A Phase 3 study testing Vitamin D3 (cholecalciferol) in people with Pregnancy, run by The Hospital for Sick Children 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
Search all trials

Trial summary

The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3 supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum vitamin D3 supplementation (28,000 IU/week)… Read more about this study

Who is it for?
Ages 18 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
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
1,300 participants
Where
1 siteBangladesh
Study dates
Mar 2014to Mar 2018
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 to 100 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women aged 18 years and above.
  • Gestational age of 17 to 24 completed weeks estimated based on recalled last menstrual period (LMP) and/or ultrasound.
  • Intends to permanently reside in the trial catchment area for at least 18 months.

Who cannot join

  • History of medical conditions that may predispose the participant to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, or history of renal calculi.
  • High-risk pregnancy based on one or more of the following findings by point-of-care testing:
  • Severe anemia: hemoglobin <70 g/L assessed by Hemocue
  • Moderate-severe proteinuria: ≥ 300 mg/dl (3+ or 4+) based on urine dipstick
  • Hypertension: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg
  • Multiple gestation, major congenital anomaly, or severe oligohydramnios based on maternal history and/or ultrasound.
Show all 9Show fewer
  • Unwillingness to stop taking non-study vitamin D or calcium supplements or a multivitamin with calcium and/or vitamin D.
  • Currently prescribed vitamin D supplements as part of a physician's treatment plan for vitamin D deficiency.
  • Previous participation in the same study.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka

Other trials in Bangladesh

About this study

Official title: Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh.

The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3 supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1 year of age among infants born to women who received vitamin D 28,000 U/week during pregnancy. Infants enrolled in the study will be followed for 2 years to document the persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300 pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months postpartum. In addition to linear length, the trial will include analyses of inflammatory and hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D metabolism, and diarrheal and respiratory morbidity in the infants.

Conditions
Pregnancy
Being tested
Vitamin D3 (cholecalciferol), Placebo
Keywords
Pregnancy, Infant Growth, Vitamin D, Bangladesh

What participants receive

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

  • Vitamin D3 (cholecalciferol)Dietary supplement

    The intervention is an oral tablet containing vitamin D3 (cholecalciferol). This vitamin D supplement will be provided in the form of small tablets (approximately 10 mm diameter) and will be custom- manufactured by Toronto Institute for Pharmaceutical Technology (TIPT) in Toronto, Ontario, Canada. Each weekly dose will consist of a single tablet. Across trial groups, the tablets will only vary with respect to the vitamin D3 dose, as described above.

  • PlaceboDietary supplement

    This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.

Study groups in NCT01924013
Study groupRoleWhat they receive
Group APlacebo comparatorPrenatal Period 0 IU; Postpartum Period 0 IU (placebo) Overall:The Prenatal Period will start at enrolment (17-24 weeks gestation) and last until delivery. The Postpartum Period will last from delivery until 6 months postpartum.
Receives: Dietary Supplement: Placebo
Group BExperimentalPrenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
Receives: Dietary Supplement: Vitamin D3 (cholecalciferol); Dietary Supplement: Placebo
Group CExperimentalPrenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
Receives: Dietary Supplement: Vitamin D3 (cholecalciferol); Dietary Supplement: Placebo
Group DExperimentalPrenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
Receives: Dietary Supplement: Vitamin D3 (cholecalciferol); Dietary Supplement: Placebo
Group EExperimentalPrenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 28,000 IU/week(=4,000 IU/d)
Receives: Dietary Supplement: Vitamin D3 (cholecalciferol)

What is being measured

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

  1. Infant Length-for-Age Z-Scores with Prenatal Supplementation

    Measured: 1 year of age

  2. Infant Length-for-Age Z-Scores with Postpartum Supplementation

    A separate analysis will be performed to assess the effect of continuation of 28,000 IU/week postpartum supplementation versus placebo (postpartum) among participants randomized to 28,000 IU/week prenatal.

    Measured: 1 year of age

Secondary outcomes (1)

  1. Serum calcium

    Maternal serum calcium will be measured during pregnancy as a primary biochemical safety parameter and post partum.

    Measured: 17 weeks gestation to birth (prenatal) and over 2 years postpartum

Timeline

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

  1. First posted16 Aug 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2017
  4. Study completionMar 2018

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01924013
Sponsor's protocol ID
1000039072
Acronym
MDIG
Status last verified
Aug 2018
First submitted
13 Aug 2013
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Siddiquee T, Bhowmik B, Munir SB, Nasrin H, Islam T, Debnath PR, Mahmud F, Nesa LQ, Afroz T, Akhtar S, Khan FR, Khan S, Khan AR, Hitman GA, Khan AKA. Determinants of Pregnancy-Related Misconceptions Among Pregnant Women in Urban Bangladesh: A Cross-Sectional Study. Public Health Chall. 2026 Aug 10;5(3):e70337. doi: 10.1002/puh2.70337. eCollection 2026 Sep.

    PubMed 42577902

  • O'Callaghan KM, Funk C, Fariha F, Nagaria MH, Dasiewicz A, Harrington J, Mahmud AA, Abrams SA, Ahmed T, Moore DR, Roth DE. Serum 25-Hydroxyvitamin D and Intact Parathyroid Hormone as Functional Biomarkers of Bone Mass in Early Childhood. J Nutr. 2025 Jun;155(6):1782-1794. doi: 10.1016/j.tjnut.2025.03.022. Epub 2025 Mar 24.

    PubMed 40139482

  • 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

  • Pell LG, Ohuma EO, Yonemitsu C, Loutet MG, Ahmed T, Mahmud AA, Azad MB, Bode L, Roth DE. The Human-Milk Oligosaccharide Profile of Lactating Women in Dhaka, Bangladesh. Curr Dev Nutr. 2021 Nov 13;5(12):nzab137. doi: 10.1093/cdn/nzab137. eCollection 2021 Dec.

    PubMed 34993388

  • O'Callaghan KM, Shanta SS, Fariha F, Harrington J, Mahmud AA, Emdin AL, Gernand AD, Ahmed T, Abrams SA, Moore DR, Roth DE. Effect of maternal prenatal and postpartum vitamin D supplementation on offspring bone mass and muscle strength in early childhood: follow-up of a randomized controlled trial. Am J Clin Nutr. 2022 Mar 4;115(3):770-780. doi: 10.1093/ajcn/nqab396.

    PubMed 34849536

  • Jukic AMZ, Zuchniak A, Qamar H, Ahmed T, Mahmud AA, Roth DE. Vitamin D Treatment during Pregnancy and Maternal and Neonatal Cord Blood Metal Concentrations at Delivery: Results of a Randomized Controlled Trial in Bangladesh. Environ Health Perspect. 2020 Nov;128(11):117007. doi: 10.1289/EHP7265. Epub 2020 Nov 23.

    PubMed 33226277

  • Subramanian A, Korsiak J, Murphy KE, Al Mahmud A, Roth DE, Gernand AD. Effect of vitamin D supplementation during pregnancy on mid-to-late gestational blood pressure in a randomized controlled trial in Bangladesh. J Hypertens. 2021 Jan;39(1):135-142. doi: 10.1097/HJH.0000000000002609.

    PubMed 32773651

  • Jeong JH, Korsiak J, Papp E, Shi J, Gernand AD, Al Mahmud A, Roth DE. Determinants of Vitamin D Status of Women of Reproductive Age in Dhaka, Bangladesh: Insights from Husband-Wife Comparisons. Curr Dev Nutr. 2019 Oct 7;3(11):nzz112. doi: 10.1093/cdn/nzz112. eCollection 2019 Nov.

    PubMed 31723723

  • Roth DE, Morris SK, Zlotkin S, Gernand AD, Ahmed T, Shanta SS, Papp E, Korsiak J, Shi J, Islam MM, Jahan I, Keya FK, Willan AR, Weksberg R, Mohsin M, Rahman QS, Shah PS, Murphy KE, Stimec J, Pell LG, Qamar H, Al Mahmud A. Vitamin D Supplementation in Pregnancy and Lactation and Infant Growth. N Engl J Med. 2018 Aug 9;379(6):535-546. doi: 10.1056/NEJMoa1800927.

    PubMed 30089075

  • Roth DE, Gernand AD, Morris SK, Pezzack B, Islam MM, Dimitris MC, Shanta SS, Zlotkin SH, Willan AR, Ahmed T, Shah PS, Murphy KE, Weksberg R, Choufani S, Shah R, Al Mahmud A. Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial. Trials. 2015 Jul 14;16:300. doi: 10.1186/s13063-015-0825-8.

    PubMed 26169781

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D3 (cholecalciferol) in people with Pregnancy, run by The Hospital for Sick Children 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 3 inclusion and 9 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 31 Aug 2018. 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 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?

Infant Length-for-Age Z-Scores with Prenatal Supplementation (time frame: 1 year of age). The study lists 2 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 NCT01924013, which also lists 10 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 31 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in