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

University of Aarhus

Status: Unknown

Conditions: Birth Weight; Vitamin D Deficiency; Pregnancy

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

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

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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