Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants (PA 03-103)

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 3

Conditions: Vitamin D Deficiency

Treatments: Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3)

Study type: Interventional

Funder types: Other

Identifiers

NCT00610688

2008-0931

Details and patient eligibility

About

The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

Full description

Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.

Enrollment: 192 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women who are within the ages of 18-45 years
• In good general health
• 12 weeks pregnant (based on last menstrual period)

Exclusion criteria

• Mothers with preexisting type I or type II diabetes
• Mothers with preexisting hypertension
• Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
• Mothers with multiple fetuses (e.g., twins, triplets, etc.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 3 patient groups, including a placebo group

Prenatal Vitamin D3

Placebo Comparator group

Description:

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D

Treatment:

Drug: Prenatal Vitamin

2

Experimental group

Description:

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)

Treatment:

Drug: Cholecalciferol (Vitamin D3)

Drug: Prenatal Vitamin

Drug: Cholecalciferol (Vitamin D3)

3

Experimental group

Description:

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Treatment:

Drug: Cholecalciferol (Vitamin D3)

Drug: Prenatal Vitamin

Drug: Cholecalciferol (Vitamin D3)