Trial Outcomes & Findings for Evaluation of Vitamin D Requirements During Pregnancy (NCT NCT00292591)

NCT ID: NCT00292591

Last Updated: 2016-09-19

Results Overview

Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 501 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2016-09-19

Participant Flow

Participant milestones

Measure	Cholecalciferol-400 IU Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 2000 IU Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 4000 IU Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Overall Study STARTED	166	167	168
Overall Study COMPLETED	102	111	110
Overall Study NOT COMPLETED	64	56	58

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Vitamin D Requirements During Pregnancy

Baseline characteristics by cohort

Measure	Cholecalciferol-400 IU n=166 Participants Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 2000 IU n=167 Participants Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 4000 IU n=168 Participants Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Total n=501 Participants Total of all reporting groups
Age, Continuous	26.4 years STANDARD_DEVIATION 5.6 • n=5 Participants	26.7 years STANDARD_DEVIATION 5.5 • n=7 Participants	26.4 years STANDARD_DEVIATION 5.4 • n=5 Participants	26.5 years STANDARD_DEVIATION 5.5 • n=4 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	167 Participants n=7 Participants	168 Participants n=5 Participants	501 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 7 months

Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery

Outcome measures

Measure	Cholecalciferol-400 IU n=102 Participants Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 2000 IU n=111 Participants Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 4000 IU n=110 Participants Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
25-Hydroxyvitamin D Concentration	32.5 ng/mL Standard Deviation 14.4	41.0 ng/mL Standard Deviation 14.6	45.7 ng/mL Standard Deviation 14.3

Adverse Events

Cholecalciferol-400 IU

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Cholecalciferol 2000 IU

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Cholecalciferol 4000 IU

Serious events: 13 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cholecalciferol-400 IU n=166 participants at risk Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 2000 IU n=167 participants at risk Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 4000 IU n=168 participants at risk Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Pregnancy, puerperium and perinatal conditions Pregnancy loss (miscarriage/fetal death)	5.4% 9/166 • Number of events 9	2.4% 4/167 • Number of events 4	7.7% 13/168 • Number of events 13

Other adverse events

Measure	Cholecalciferol-400 IU n=166 participants at risk Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 2000 IU n=167 participants at risk Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy	Cholecalciferol 4000 IU n=168 participants at risk Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Pregnancy, puerperium and perinatal conditions Complications of Pregnancy	13.3% 22/166 • Number of events 22	21.0% 35/167 • Number of events 35	16.1% 27/168 • Number of events 27

Additional Information

Dr. Carol Wagner

Medical University of South Carolina

Phone: 18437922112

Email: wagnercl@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place