Birth Weight, Pregnancy, Vitamin D Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCholecalciferol 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.
OTHERplacebo tablet
placebo 2 tablet, once a day,
DIETARY_SUPPLEMENTCholecalciferol (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.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Birth Weight | 0-24 hours after delivery of the child |
Secondary
| Measure | Time frame |
|---|---|
| Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD). | Day 1 to 4 months after delivery. |
| Infections of the newborn | Day 1 of the child to 16 weeks after birth. |
| Growth of the newborn measured by weight, crown-heel length and head circumference | Day 1 of the child to 16 weeks after birth |
| Time to accomplish pregnancy | 0-12 months |
Countries
Denmark
Contacts
Primary ContactGitte Bloch Rasmussen, MD
Backup ContactLars Rejnmark, MD, PhD, DrMed
Outcome results
None listed