Trial Outcomes & Findings for Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants (NCT NCT00610688)
NCT ID: NCT00610688
Last Updated: 2021-10-19
Results Overview
Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
12, 16, 28 weeks and at maternal delivery and neonatal birth
Results posted on
2021-10-19
Participant Flow
Participant milestones
| Measure |
400 IU
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
|
2000 IU
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
|
4000 IU
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
63
|
|
Overall Study
COMPLETED
|
55
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Baseline characteristics by cohort
| Measure |
400 IU
n=64 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
|
2000 IU
n=65 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
|
4000 IU
n=63 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
192 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
|
|
Region of Enrollment
United Arab Emirates
|
64 participants
n=5 Participants
|
65 participants
n=7 Participants
|
63 participants
n=5 Participants
|
192 participants
n=4 Participants
|
|
Maternal serum 25 hydroxy Vitamin D (25(OH)D)
|
21.5 nmol/L
STANDARD_DEVIATION 13.0 • n=5 Participants
|
20.5 nmol/L
STANDARD_DEVIATION 11.9 • n=7 Participants
|
19.6 nmol/L
STANDARD_DEVIATION 7.7 • n=5 Participants
|
20.7 nmol/L
STANDARD_DEVIATION 11.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12, 16, 28 weeks and at maternal delivery and neonatal birthPopulation: Intention to treat analysis.
Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement
Outcome measures
| Measure |
400 IU
n=55 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
|
2000 IU
n=52 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
|
4000 IU
n=55 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
|
|---|---|---|---|
|
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Maternal at 16 Weeks
|
40.7 nmol/L
Standard Error 2.1
|
53.7 nmol/L
Standard Error 2.3
|
60.7 nmol/L
Standard Error 3.3
|
|
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Maternal at 28 Weeks
|
53.9 nmol/L
Standard Error 3.2
|
82.3 nmol/L
Standard Error 4.4
|
88.2 nmol/L
Standard Error 4.2
|
|
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Maternal at 12 Weeks
|
21.5 nmol/L
Standard Error 1.6
|
20.5 nmol/L
Standard Error 1.5
|
19.6 nmol/L
Standard Error 1.0
|
|
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Maternal at Delivery
|
48.2 nmol/L
Standard Error 3.1
|
64.9 nmol/L
Standard Error 4.0
|
89.8 nmol/L
Standard Error 4.6
|
|
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Neonatal at Birth
|
36.9 nmol/L
Standard Error 2.8
|
48.3 nmol/L
Standard Error 3.5
|
66.1 nmol/L
Standard Error 3.2
|
SECONDARY outcome
Timeframe: At deliveryGrowth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth
Outcome measures
| Measure |
400 IU
n=55 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
|
2000 IU
n=52 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
|
4000 IU
n=55 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
|
|---|---|---|---|
|
Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
Heel Crown Length
|
51.9 cm
Standard Deviation 2.2
|
51.6 cm
Standard Deviation 2.8
|
50.9 cm
Standard Deviation 3.7
|
|
Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
Head Circumference
|
34.1 cm
Standard Deviation 1.4
|
34.5 cm
Standard Deviation 2.0
|
33.9 cm
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Measured at birth.Growth of the Newborn Infant as Measured by Birthweight in grams.
Outcome measures
| Measure |
400 IU
n=55 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
|
2000 IU
n=52 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
|
4000 IU
n=55 Participants
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
|
|---|---|---|---|
|
Birthweight of Newborn Infant
|
3100 Grams
Standard Deviation 374
|
3191 Grams
Standard Deviation 492
|
3103 Grams
Standard Deviation 639
|
Adverse Events
400 IU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2000 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
Dr. Adekunle Dawodu
Cincinnati Children's Hospital Medical Center
Phone: 513-636-1966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place