Maternal Vitamin D for Infant Growth (MDIG) Trial

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014