Trial Outcomes & Findings for Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia (NCT NCT03101150)

NCT ID: NCT03101150

Last Updated: 2018-11-02

Results Overview

Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 179 participants
• Primary outcome timeframe: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
• Results posted on: 2018-11-02

Participant Flow

416 participants were screened. 192 did not meet eligibility criteria. 38 refused to participate and 7 turned out to be ectopic pregnancy.

Participant milestones

Measure	400 IU Materna tablet once daily orally from 14 weeks of pregnancy til delivery.	4000 IU Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
Overall Study STARTED	86	93
Overall Study COMPLETED	81	83
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Measure	400 IU Materna tablet once daily orally from 14 weeks of pregnancy til delivery.	4000 IU Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
Overall Study Lost to Follow-up	2	4
Overall Study Miscarriage	3	6

Baseline Characteristics

Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia

Baseline characteristics by cohort

Measure	400 IU Vitamin D3 n=86 Participants 400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. 400 IU Vitamin D3: Antenatal multivitamin	4000 IU Vitamin D3 n=93 Participants 4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery. 4000 IU Vitamin D3: 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily	Total n=179 Participants Total of all reporting groups
Age, Continuous	29.3 years STANDARD_DEVIATION 5.3 • n=5 Participants	29.4 years STANDARD_DEVIATION 4.8 • n=7 Participants	29.3 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	93 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Saudi Arabia	80 Participants n=5 Participants	80 Participants n=7 Participants	160 Participants n=5 Participants
Region of Enrollment India	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Philippines	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Africa	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Body Mass Index (BMI)	28.8 Kg/m2 STANDARD_DEVIATION 7.3 • n=5 Participants	28.1 Kg/m2 STANDARD_DEVIATION 7.2 • n=7 Participants	28.4 Kg/m2 STANDARD_DEVIATION 7.2 • n=5 Participants
Primiparity	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.

Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.

Outcome measures

Measure	400 IU n=81 Participants Materna tablet once daily orally from 14 weeks of pregnancy til delivery.	4000 IU n=83 Participants Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
Number of Participants With Pre-eclampsia in Both Arms	6 Participants	1 Participants

SECONDARY outcome

Timeframe: At 36th week of pregnancy

Population: Out of 86 participants randomized for the arm of 400 IU, 3 had miscarriage and 2 lost to follow. So 81 participants were analyzed. Out of 93 participants randomized for the arm of 4000 IU, 6 had miscarriage and 4 lost to follow. So 83 were analyzed in that arm.

Level of Improvement in Vitamin D status in both arms

Outcome measures

Measure	400 IU n=81 Participants Materna tablet once daily orally from 14 weeks of pregnancy til delivery.	4000 IU n=83 Participants Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
Change in Vitamin D Level	35.3 nmol/L Standard Deviation 20.7	72.3 nmol/L Standard Deviation 30.9

SECONDARY outcome

Timeframe: At delivery

Patients having fetus with retardation of growth in both arms.

Outcome measures

Measure	400 IU n=81 Participants Materna tablet once daily orally from 14 weeks of pregnancy til delivery.	4000 IU n=83 Participants Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.
Number of Patients With Intrauterine Growth Retardation	18 Participants	8 Participants

Adverse Events

400 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4000 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Consultant Obstetritian and Gynecologist

King Fahd Medical City

Phone: 00966539417217

Email: amali@kfmc.med.sa

Results disclosure agreements

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