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

NCT ID: NCT01038453

Last Updated: 2011-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Birth Weight Vitamin D Deficiency Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cholecalciferol (Vitamin D3) 35 µg

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol 35 µg per day

Intervention Type DIETARY_SUPPLEMENT

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.

Cholecalciferol (Vitamin D3) 70 µg

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol (Vitamin D3) 70 µg

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

placebo tablet

Intervention Type OTHER

placebo 2 tablet, once a day,

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

placebo tablet

placebo 2 tablet, once a day,

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gitte Bloch Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Lars Rejnmark, MD, PhD, Drmed.

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

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University of Aarhus, Aarhus Universityhospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Gitte Bloch Rasmussen, MD

Role: CONTACT

[email protected]
+45 89 4976 81

Lars Rejnmark, MD, PhD, DrMed

Role: CONTACT

[email protected]

Facility Contacts

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Gitte Bloch Rasmussen, MD

Role: primary

[email protected]
+45 89 49 76 81

Lars Rjenmark, MD,PhD,DrMed

Role: backup

[email protected]

References

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Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

Reference Type DERIVED
PMID: 39077939 (View on PubMed)

Other Identifiers

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M-20090097

Identifier Type: -

Identifier Source: org_study_id