Maternal Vitamin D for Infant Growth (MDIG) Trial

This study is currently recruiting participants.
Verified March 2014 by The Hospital for Sick Children
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Shimantik
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01924013
First received: August 13, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pregnancy
Dietary Supplement: Vitamin D3 (cholecalciferol)
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Infant Length-for-Age Z-Scores with Prenatal Supplementation [ Time Frame: 1 year of age ] [ Designated as safety issue: No ]
  • Infant Length-for-Age Z-Scores with Postpartum Supplementation [ Time Frame: 1 year of age ] [ Designated as safety issue: No ]
    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:
  • Serum calcium [ Time Frame: 17 weeks gestation to birth (prenatal) and over 2 years postpartum ] [ Designated as safety issue: Yes ]
    Maternal serum calcium will be measured during pregnancy as a primary biochemical safety parameter and post partum.


Other Outcome Measures:
  • Stunting (LAZ < -2 SD below the median) at 1 and 2 years of age. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
  • Attained length and LAZ at 2 years of age. [ Time Frame: 2 years postnatal ] [ Designated as safety issue: No ]
  • Birth weight, low birth weight %, small-for-gestational age % [ Time Frame: Birth ] [ Designated as safety issue: No ]
  • Preterm birth % [ Time Frame: Birth ] [ Designated as safety issue: Yes ]
  • Stillbirth % [ Time Frame: 17 weeks gestation to 39 weeks ] [ Designated as safety issue: Yes ]
    Prenatal period

  • Maternal, perinatal, neonatal and infant severe morbidity and mortality [ Time Frame: From 17 weeks gestation to 6 months postpartum ] [ Designated as safety issue: Yes ]
    During intervention phase (prenatal and first 6 months postpartum)

  • Infant acute respiratory infections and diarrhea [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    first 6 months postnatal

  • 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 ] [ Designated as safety issue: No ]
    Prenatal and first 2 years postnatal

  • Epigenetic patterns of genes involved in vitamin D metabolism. [ Time Frame: Birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: March 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A

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.

Dietary Supplement: Placebo
This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.
Experimental: Group B
Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
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.
Experimental: Group C
Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
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.
Experimental: Group D
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
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.
Experimental: Group E
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 28,000 IU/week(=4,000 IU/d)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01924013

Contacts
Contact: Daniel Roth, MD (416) 813-5795 daniel.roth@sickkids.ca

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh Recruiting
Dhaka, Bangladesh
Contact: Abdullah Al Mahmud       mahmud@icddrb.org   
Principal Investigator: Abdullah Al Mahmud         
Sponsors and Collaborators
The Hospital for Sick Children
International Centre for Diarrhoeal Disease Research, Bangladesh
Shimantik
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Daniel Roth, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01924013     History of Changes
Other Study ID Numbers: 1000039072
Study First Received: August 13, 2013
Last Updated: March 20, 2014
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by The Hospital for Sick Children:
Pregnancy
Infant Growth
Vitamin D
Bangladesh

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 21, 2014