Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight
Gravita
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 4, 2011
November 1, 2011
2 years
December 18, 2009
November 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Birth Weight
0-24 hours after delivery of the child
Secondary Outcomes (4)
Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
Day 1 to 4 months after delivery.
Infections of the newborn
Day 1 of the child to 16 weeks after birth.
Growth of the newborn measured by weight, crown-heel length and head circumference
Day 1 of the child to 16 weeks after birth
Time to accomplish pregnancy
0-12 months
Study Arms (3)
Cholecalciferol (Vitamin D3) 35 µg
ACTIVE COMPARATORDietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day
Cholecalciferol (Vitamin D3) 70 µg
ACTIVE COMPARATORDietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day
placebo
PLACEBO COMPARATORInterventions
Cholecalciferol (Vitamin D3) oral 1 tablet 35 µg per day. Placebo oral 1 tablet per day. In total 35 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery.
Cholecalciferol (Vitamin D3) oral 2 tablets each containing 35 µg. In total 70 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery.
Eligibility Criteria
You may qualify if:
- P-OH25-vitamin D \< 50 nmol/l
- Woman age 30-35 years
- In good general health
You may not qualify if:
- Infertility
- Intake of 400 IU or more Vitamin D/day
- Cancer
- Alcohol or drug abuse
- Calciummetabolic disturbances
- Spontaneous abortion within last 6 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Aarhus, Aarhus Universityhospital
Aarhus, Denmark
Related Publications (1)
Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
PMID: 39077939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gitte Bloch Rasmussen, MD
Aarhus University Hospital
- STUDY DIRECTOR
Lars Rejnmark, MD, PhD, Drmed.
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2009
First Posted
December 24, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
November 4, 2011
Record last verified: 2011-11