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

Pregnancy Clinical Trial

— Gravita  

Official title:

Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01038453
• Other study ID #: M-20090097
• Status: Unknown status
• Phase: N/A
• First received: December 18, 2009
• Last updated: November 3, 2011
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: Gitte Bloch Rasmussen, MD
• Phone: +45 89 4976 81
• Email: gittebr[@]ki.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 400
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Pregnancy
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol 35 µg per day
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.

Other:
• placebo tablet
placebo 2 tablet, once a day,

Dietary Supplement:
• Cholecalciferol (Vitamin D3) 70 µg
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.

Locations

Country	Name	City	State
Denmark	University of Aarhus, Aarhus Universityhospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Weight		0-24 hours after delivery of the child
Secondary	Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).		Day 1 to 4 months after delivery.
Secondary	Infections of the newborn		Day 1 of the child to 16 weeks after birth.
Secondary	Growth of the newborn measured by weight, crown-heel length and head circumference		Day 1 of the child to 16 weeks after birth
Secondary	Time to accomplish pregnancy		0-12 months