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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01038453
First received: December 18, 2009
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Birth Weight
Vitamin D Deficiency
Pregnancy
Dietary Supplement: Cholecalciferol 35 µg per day
Other: placebo tablet
Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Birth Weight [ Time Frame: 0-24 hours after delivery of the child ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD). [ Time Frame: Day 1 to 4 months after delivery. ] [ Designated as safety issue: No ]
  • Infections of the newborn [ Time Frame: Day 1 of the child to 16 weeks after birth. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to accomplish pregnancy [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Placebo Comparator: placebo Other: placebo tablet
placebo 2 tablet, once a day,

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038453

Contacts
Contact: Gitte Bloch Rasmussen, MD +45 89 4976 81 gittebr@ki.au.dk
Contact: Lars Rejnmark, MD, PhD, DrMed rejnmark@post6.tele.dk

Locations
Denmark
University of Aarhus, Aarhus Universityhospital Recruiting
Aarhus, Denmark
Contact: Gitte Bloch Rasmussen, MD    +45 89 49 76 81    gittebr@ki.au.dk   
Contact: Lars Rjenmark, MD,PhD,DrMed       rejnmark@post6.tele.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Gitte Bloch Rasmussen, MD Aarhus University Hospital
Study Director: Lars Rejnmark, MD, PhD, Drmed. Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01038453     History of Changes
Other Study ID Numbers: M-20090097
Study First Received: December 18, 2009
Last Updated: November 3, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Birth Weight
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014