CClinicalTrials.gg
Status unknownNCT01038453GravitaUpdated Nov 4, 2011

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

An interventional study of Cholecalciferol 35 µg per day and placebo tablet in Birth Weight, Vitamin D Deficiency and Pregnancy, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-04.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Birth Weight
  • Vitamin D Deficiency
  • Pregnancy
03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's planned enrollment of 400 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • P-OH25-vitamin D \< 50 nmol/l
  • Woman age 30-35 years
  • In good general health

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Cholecalciferol (Vitamin D3) 35 µg

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

    Dietary Supplement: Cholecalciferol 35 µg per day

  • Active comparator
    Cholecalciferol (Vitamin D3) 70 µg

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

    Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg

  • Placebo comparator
    placebo

    Other: placebo tablet

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.

06

What researchers measure

Primary outcomes

  1. Birth Weight

    Time frame: 0-24 hours after delivery of the child

Secondary outcomes

  1. Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).

    Time frame: Day 1 to 4 months after delivery.

  2. Infections of the newborn

    Time frame: Day 1 of the child to 16 weeks after birth.

  3. 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

  4. Time to accomplish pregnancy

    Time frame: 0-12 months

07

Study locations

1 of 1 sites recruiting
  • University of Aarhus, Aarhus Universityhospital
    Aarhus, Denmark
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01038453
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Dec 24, 2009
Start date
Dec 2009
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Nov 4, 2011

Study contacts

Gitte Bloch Rasmussen, MD
Contact
gittebr@ki.au.dk
+45 89 4976 81
Lars Rejnmark, MD, PhD, DrMed
Contact
rejnmark@post6.tele.dk
Gitte Bloch Rasmussen, MD
principal investigator · Aarhus University Hospital
Lars Rejnmark, MD, PhD, Drmed.
study director · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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