Trial Outcomes & Findings for Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina (NCT NCT00412087)

Results Overview

25-hydroxyvitamin D at Visit 7, one month prior to delivery

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

564 participants

Primary outcome timeframe

7 months

Results posted on

2016-07-29

Participant Flow

564 women consented to participate in Aim 1 of the study (collection of cross-sectional baseline measures only). Of those 564 women, 265 were enrolled in Aim 2 of the study; only the Aim 2 cohort were randomized to intervention groups and followed through delivery.

Participant milestones

Participant milestones
Measure	Cholecalciferol 2000 IU Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Cholecalciferol 4000 IU Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
Overall Study STARTED	134	131
Overall Study COMPLETED	72	66
Overall Study NOT COMPLETED	62	65

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholecalciferol 2000 IU n=134 Participants Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Cholecalciferol 4000 IU n=131 Participants Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Total n=265 Participants Total of all reporting groups
Age, Continuous	24.4 years STANDARD_DEVIATION 5.5 • n=5 Participants	25.2 years STANDARD_DEVIATION 4.8 • n=7 Participants	24.8 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	134 Participants n=5 Participants	131 Participants n=7 Participants	265 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

25-hydroxyvitamin D at Visit 7, one month prior to delivery

Outcome measures

Outcome measures
Measure	Cholecalciferol 2000 IU n=72 Participants Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Cholecalciferol 4000 IU n=66 Participants Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
25-hydroxyvitamin D at Visit 7	36.7 ng/mL Standard Deviation 14.9	39.8 ng/mL Standard Deviation 12.9

SECONDARY outcome

Timeframe: 7 months

Population: There was 1 subject in the 2000 IU group and 3 subjects in the 4000 IU group missing PTH measurements.

Intact parathyroid hormone at Visit 7, one month prior to delivery

Outcome measures

Outcome measures
Measure	Cholecalciferol 2000 IU n=71 Participants Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Cholecalciferol 4000 IU n=63 Participants Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
Parathyroid Hormone at Visit 7	17.3 pg/mL Standard Deviation 8.3	14.3 pg/mL Standard Deviation 6.9

Adverse Events

Cholecalciferol 2000 IU

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Cholecalciferol 4000 IU

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cholecalciferol 2000 IU n=134 participants at risk Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Cholecalciferol 4000 IU n=131 participants at risk Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
Pregnancy, puerperium and perinatal conditions Fetal loss	3.7% 5/134 • Number of events 5	1.5% 2/131 • Number of events 2

Other adverse events

Other adverse events
Measure	Cholecalciferol 2000 IU n=134 participants at risk Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	Cholecalciferol 4000 IU n=131 participants at risk Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
Pregnancy, puerperium and perinatal conditions Complications of Pregnancy	22.4% 30/134 • Number of events 30	15.3% 20/131 • Number of events 20

Additional Information

Dr. Carol Wagner

Medical University of South Carolina

Phone: 18437922112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place