Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments vitamin d3 (cholecalciferol), placebo
Phase phase 3
Sponsor The Hospital for Sick Children
Collaborator International Centre for Diarrhoeal Disease Research, Bangladesh
Start date March 2014
End date February 2017
Trial size 1300 participants
Trial identifier NCT01924013, 1000039072

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Placebo Comparator)
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.
placebo
This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.
(Experimental)
Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
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.
(Experimental)
Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
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.
(Experimental)
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
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.
(Experimental)
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 28,000 IU/week(=4,000 IU/d)
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.

Primary Outcomes

Measure
Infant Length-for-Age Z-Scores with Prenatal Supplementation
time frame: 1 year of age
Infant Length-for-Age Z-Scores with Postpartum Supplementation
time frame: 1 year of age

Secondary Outcomes

Measure
Serum calcium
time frame: 17 weeks gestation to birth (prenatal) and over 2 years postpartum

Eligibility Criteria

Female participants from 18 years up to 100 years old.

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.

Additional Information

Official title Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh.
Principal investigator Daniel Roth, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.