Conditions: Vitamin D Deficiency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 192
Healthy volunteers: yes

Brief summary:
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.

Detailed 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.

Arms:
arm 1: Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D arm 2: Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3) arm 3: Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Interventions: intervention 1: Prenatal Vitamin intervention 2: Cholecalciferol (Vitamin D3) intervention 3: Cholecalciferol (Vitamin D3)
Intervention descriptions: intervention 1: Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery intervention 2: Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery intervention 3: Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Protocol document: