Skip to main content
OpenTrials
Completed

NCT Number: NCT01924013

Maternal Vitamin D for Infant Growth (MDIG) Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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.

Placebo

Dietary Supplement

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

Primary outcomes

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

    Time frame: 1 year of age

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

    Time frame: 1 year of age

    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.

Secondary outcomes

  1. Serum calcium

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

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

Other outcomes

  1. Stunting (LAZ < -2 SD below the median) at 1 and 2 years of age.

    Time frame: 1-2 years

  2. Attained length and LAZ at 2 years of age.

    Time frame: 2 years postnatal

  3. Birth weight, low birth weight %, small-for-gestational age %

    Time frame: Birth

  4. Preterm birth %

    Time frame: Birth

  5. Stillbirth %

    Time frame: 17 weeks gestation to 39 weeks

    Prenatal period

  6. Maternal, perinatal, neonatal and infant severe morbidity and mortality

    Time frame: From 17 weeks gestation to 6 months postpartum

    During intervention phase (prenatal and first 6 months postpartum)

  7. Infant acute respiratory infections and diarrhea

    Time frame: 6 months postpartum

    first 6 months postnatal

  8. Biomarker concentrations (specific hormones, nutrients, environmental contaminants, and inflammatory markers potentially involved in the mediation or modification of the effect of vitamin D on infant stunting).

    Time frame: 17 weeks gestation to 2 years postpartum

    Prenatal and first 2 years postnatal

  9. Epigenetic patterns of genes involved in vitamin D metabolism.

    Time frame: Birth

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Shimantik

Registry information

Official study title

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

Acronym: MDIG

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Aug 16, 2013
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.