Maternal Vitamin D for Infant Growth (MDIG) Trial
This trial is active, not recruiting.
|Treatments||vitamin d3 (cholecalciferol), placebo|
|Sponsor||The Hospital for Sick Children|
|Collaborator||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Start date||March 2014|
|End date||February 2017|
|Trial size||1300 participants|
|Trial identifier||NCT01924013, 1000039072|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Infant Length-for-Age Z-Scores with Prenatal Supplementation
time frame: 1 year of age
Infant Length-for-Age Z-Scores with Postpartum Supplementation
time frame: 1 year of age
time frame: 17 weeks gestation to birth (prenatal) and over 2 years postpartum
Female participants from 18 years up to 100 years old.
- 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.
- 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.
|Official title||Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh.|
|Principal investigator||Daniel Roth, MD|
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