Maternal Vitamin D for Infant Growth (MDIG) Trial

Pregnancy Clinical Trial

— MDIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924013
• Other study ID #: 1000039072
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh, Shimantik

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stunting (LAZ < -2 SD below the median) at 1 and 2 years of age.		1-2 years
Other	Attained length and LAZ at 2 years of age.		2 years postnatal
Other	Birth weight, low birth weight %, small-for-gestational age %		Birth
Other	Preterm birth %		Birth
Other	Stillbirth %	Prenatal period	17 weeks gestation to 39 weeks
Other	Maternal, perinatal, neonatal and infant severe morbidity and mortality	During intervention phase (prenatal and first 6 months postpartum)	From 17 weeks gestation to 6 months postpartum
Other	Infant acute respiratory infections and diarrhea	first 6 months postnatal	6 months postpartum
Other	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).	Prenatal and first 2 years postnatal	17 weeks gestation to 2 years postpartum
Other	Epigenetic patterns of genes involved in vitamin D metabolism.		Birth
Primary	Infant Length-for-Age Z-Scores with Prenatal Supplementation		1 year of age
Primary	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.	1 year of age
Secondary	Serum calcium	Maternal serum calcium will be measured during pregnancy as a primary biochemical safety parameter and post partum.	17 weeks gestation to birth (prenatal) and over 2 years postpartum