Maternal Vitamin D for Infant Growth (MDIG) Trial

Phase 3

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol)

• Registration Number: NCT01924013
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-16
• Study Start: 2014-03
• Primary Completion: 2017-03
• Study Completion: 2018-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Placebo	Prenatal 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.
Group B	Vitamin D3 (cholecalciferol)	Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
Group B	Placebo	Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
Group C	Vitamin D3 (cholecalciferol)	Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
Group C	Placebo	Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
Group D	Vitamin D3 (cholecalciferol)	Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
Group D	Placebo	Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
Group E	Vitamin D3 (cholecalciferol)	Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 28,000 IU/week(=4,000 IU/d)

Primary Outcome Measures

Name	Time	Method
Infant Length-for-Age Z-Scores with Prenatal Supplementation	1 year of age
Infant Length-for-Age Z-Scores with Postpartum Supplementation	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 Outcome Measures

Name	Time	Method
Serum calcium	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.

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh