NCT01924013

Maternal Vitamin D for Infant Growth (MDIG) Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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) 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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 (cholecalciferol)	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.
DIETARY_SUPPLEMENT	Placebo	This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-03-01
• Completion: 2018-03-01
• First posted: 2013-08-16
• Last updated: 2018-08-31

Locations

1 site across 1 country: Bangladesh