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

Primary Purpose

Birth Weight, Vitamin D Deficiency, Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol 35 µg per day
placebo tablet
Cholecalciferol (Vitamin D3) 70 µg
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Birth Weight

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Aarhus, Aarhus UniversityhospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol (Vitamin D3) 35 µg

Cholecalciferol (Vitamin D3) 70 µg

placebo

Arm Description

Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day

Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day

Outcomes

Primary Outcome Measures

Birth Weight

Secondary Outcome Measures

Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
Infections of the newborn
Growth of the newborn measured by weight, crown-heel length and head circumference
Time to accomplish pregnancy

Full Information

First Posted
December 18, 2009
Last Updated
November 3, 2011
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01038453
Brief Title
Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight
Acronym
Gravita
Official Title
Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight, Vitamin D Deficiency, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol (Vitamin D3) 35 µg
Arm Type
Active Comparator
Arm Description
Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day
Arm Title
Cholecalciferol (Vitamin D3) 70 µg
Arm Type
Active Comparator
Arm Description
Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol 35 µg per day
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo tablet
Intervention Description
placebo 2 tablet, once a day,
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol (Vitamin D3) 70 µg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Birth Weight
Time Frame
0-24 hours after delivery of the child
Secondary Outcome Measure Information:
Title
Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
Time Frame
Day 1 to 4 months after delivery.
Title
Infections of the newborn
Time Frame
Day 1 of the child to 16 weeks after birth.
Title
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
Title
Time to accomplish pregnancy
Time Frame
0-12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte Bloch Rasmussen, MD
Phone
+45 89 4976 81
Email
gittebr@ki.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Rejnmark, MD, PhD, DrMed
Email
rejnmark@post6.tele.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte Bloch Rasmussen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Rejnmark, MD, PhD, Drmed.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Aarhus, Aarhus Universityhospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Bloch Rasmussen, MD
Phone
+45 89 49 76 81
Email
gittebr@ki.au.dk
First Name & Middle Initial & Last Name & Degree
Lars Rjenmark, MD,PhD,DrMed
Email
rejnmark@post6.tele.dk

12. IPD Sharing Statement

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

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