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

November 3, 2011 updated by: University of Aarhus

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gitte Bloch Rasmussen, MD
  • Phone Number: +45 89 4976 81
  • Email: gittebr@ki.au.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • University of Aarhus, Aarhus Universityhospital
        • Contact:
          • Gitte Bloch Rasmussen, MD
          • Phone Number: +45 89 49 76 81
          • Email: gittebr@ki.au.dk
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo tablet
placebo 2 tablet, once a day,
Active Comparator: Cholecalciferol (Vitamin D3) 35 µg
Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day
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.
Active Comparator: Cholecalciferol (Vitamin D3) 70 µg
Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Birth Weight
Time Frame: 0-24 hours after delivery of the child
0-24 hours after delivery of the child

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
Time Frame: Day 1 to 4 months after delivery.
Day 1 to 4 months after delivery.
Infections of the newborn
Time Frame: Day 1 of the child to 16 weeks after birth.
Day 1 of the child to 16 weeks after birth.
Growth of the newborn measured by weight, crown-heel length and head circumference
Time Frame: Day 1 of the child to 16 weeks after birth
Day 1 of the child to 16 weeks after birth
Time to accomplish pregnancy
Time Frame: 0-12 months
0-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Gitte Bloch Rasmussen, MD, Aarhus University Hospital
  • Study Director: Lars Rejnmark, MD, PhD, Drmed., Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

December 18, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

November 3, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20090097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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