Trial Outcomes & Findings for Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation (NCT NCT01932788)
NCT ID: NCT01932788
Last Updated: 2018-11-21
Results Overview
Because the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who had greater than 100 nmol/L of 25(OH)D. Recording will be counts of participants in each arm that achieved greater than the 100 nmol/L threshold.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
342 participants
Primary outcome timeframe
20 weeks
Results posted on
2018-11-21
Participant Flow
Participant milestones
| Measure |
Vitamin D 4000 IU
Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.
Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
|
Placebo Gummy Vitamin
Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)
Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
169
|
|
Overall Study
COMPLETED
|
135
|
118
|
|
Overall Study
NOT COMPLETED
|
38
|
51
|
Reasons for withdrawal
| Measure |
Vitamin D 4000 IU
Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.
Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
|
Placebo Gummy Vitamin
Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)
Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
18
|
0
|
|
Overall Study
Lost to Follow-up
|
18
|
46
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation
Baseline characteristics by cohort
| Measure |
Vitamin D 4000 IU
n=135 Participants
Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.
Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
|
Placebo Gummy Vitamin
n=118 Participants
Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)
Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
28.9 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
135 participants
n=5 Participants
|
118 participants
n=7 Participants
|
253 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeksBecause the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who had greater than 100 nmol/L of 25(OH)D. Recording will be counts of participants in each arm that achieved greater than the 100 nmol/L threshold.
Outcome measures
| Measure |
Vitamin D 4000 IU
n=135 Participants
Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.
Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
|
Placebo Gummy Vitamin
n=118 Participants
Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)
Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.
|
|---|---|---|
|
Number of Participants With Greater Than 100 Nmol/L 25(OH)D (Converted Vitamin D)
|
110 Participants
|
22 Participants
|
Adverse Events
Vitamin D 4000 IU
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Gummy Vitamin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D 4000 IU
n=135 participants at risk
Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.
Vitamin D3 4000 IU in gummy form: Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
|
Placebo Gummy Vitamin
n=118 participants at risk
Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)
Placebo gummy vitamin: Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Preterm birth
|
3.7%
5/135 • Number of events 5 • Duration of study, average 8 months
|
5.9%
7/118 • Number of events 7 • Duration of study, average 8 months
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
3.7%
5/135 • Number of events 5 • Duration of study, average 8 months
|
6.8%
8/118 • Number of events 8 • Duration of study, average 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place