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

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University of Aarhus

Status

Unknown

Conditions

Birth Weight
Vitamin D Deficiency
Pregnancy

Treatments

Dietary Supplement: Cholecalciferol 35 µg per day
Other: placebo tablet
Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg

Study type

Interventional

Funder types

Other

Identifiers

NCT01038453
M-20090097

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

400 participants in 3 patient groups, including a placebo group

Cholecalciferol (Vitamin D3) 35 µg
Active Comparator group
Description:
Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day
Treatment:
Dietary Supplement: Cholecalciferol 35 µg per day
Cholecalciferol (Vitamin D3) 70 µg
Active Comparator group
Description:
Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day
Treatment:
Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg
placebo
Placebo Comparator group
Treatment:
Other: placebo tablet

Trial contacts and locations

1

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Central trial contact

Lars Rejnmark, MD, PhD, DrMed; Gitte Bloch Rasmussen, MD

Data sourced from clinicaltrials.gov

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