Phase 3
N=192
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00610688 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement — 21.5; 20.5; 19.6; 40.7 nmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Prenatal Vitamin (Drug); Cholecalciferol (Vitamin D3) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement |
21.5; 20.5; 19.6; 40.7; 53.7; 60.7 | — |
| SECONDARY Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth |
51.9; 51.6; 50.9; 34.1; 34.5; 33.9 | — |
| SECONDARY Birthweight of Newborn Infant |
3100; 3191; 3103 | — |
Summary
The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.
Eligibility Criteria
Inclusion Criteria
- Women who are within the ages of 18-45 years
- In good general health
- 12 weeks pregnant (based on last menstrual period)
Exclusion Criteria
- Mothers with preexisting type I or type II diabetes
- Mothers with preexisting hypertension
- Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
- Mothers with multiple fetuses (e.g., twins, triplets, etc.)
Data sourced from ClinicalTrials.gov (NCT00610688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.