A Phase 3 interventional study of Vitamin D3 (cholecalciferol) and Placebo in Pregnancy, sponsored by The Hospital for Sick Children. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by The Hospital for Sick Children · Phase 3, Interventional, and Prevention
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.
The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
High-risk pregnancy based on one or more of the following findings by point-of-care testing:
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
Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)
Dietary Supplement: Vitamin D3 (cholecalciferol) · Dietary Supplement: Placebo
Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)
Dietary Supplement: Vitamin D3 (cholecalciferol) · Dietary Supplement: Placebo
Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)
Dietary Supplement: Vitamin D3 (cholecalciferol) · Dietary Supplement: Placebo
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.
This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.
Infant Length-for-Age Z-Scores with Prenatal Supplementation
Time frame: 1 year of age
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.
Time frame: 1 year of age
Serum calcium
Maternal serum calcium will be measured during pregnancy as a primary biochemical safety parameter and post partum.
Time frame: 17 weeks gestation to birth (prenatal) and over 2 years postpartum
Stunting (LAZ < -2 SD below the median) at 1 and 2 years of age.
Time frame: 1-2 years
Attained length and LAZ at 2 years of age.
Time frame: 2 years postnatal
Birth weight, low birth weight %, small-for-gestational age %
Time frame: Birth
Preterm birth %
Time frame: Birth
Stillbirth %
Prenatal period
Time frame: 17 weeks gestation to 39 weeks
Maternal, perinatal, neonatal and infant severe morbidity and mortality
During intervention phase (prenatal and first 6 months postpartum)
Time frame: From 17 weeks gestation to 6 months postpartum
Infant acute respiratory infections and diarrhea
first 6 months postnatal
Time frame: 6 months postpartum
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
Time frame: 17 weeks gestation to 2 years postpartum
Epigenetic patterns of genes involved in vitamin D metabolism.
Time frame: Birth
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children