Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight

Not Applicable

• Conditions: Birth Weight; Vitamin D Deficiency; Pregnancy
• Interventions: Dietary Supplement: Cholecalciferol 35 µg per day; Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg; Other: placebo tablet

• Registration Number: NCT01038453
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-24
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-03
• Last Update Posted: 2011-11-04
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• P-OH25-vitamin D < 50 nmol/l
• Woman age 30-35 years
• In good general health

Exclusion Criteria

• Infertility
• Intake of 400 IU or more Vitamin D/day
• Cancer
• Alcohol or drug abuse
• Calciummetabolic disturbances
• Spontaneous abortion within last 6 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol (Vitamin D3) 35 µg	Cholecalciferol 35 µg per day	Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day
Cholecalciferol (Vitamin D3) 70 µg	Cholecalciferol (Vitamin D3) 70 µg	Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day
placebo	placebo tablet	-

Primary Outcome Measures

Name	Time	Method
Birth Weight	0-24 hours after delivery of the child

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Aarhus, Aarhus Universityhospital; 🇩🇰 Aarhus, Denmark