Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00610688
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Collaborators:
United Arab Emirates University
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition Vitamin D Deficiency
Interventions Drug: Prenatal Vitamin
Drug: Cholecalciferol (Vitamin D3)
Enrollment 192
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 400 IU 2000 IU 4000 IU
Hide Arm/Group Description Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
Period Title: Overall Study
Started 64 65 63
Completed 55 52 55
Not Completed 9 13 8
Arm/Group Title 400 IU 2000 IU 4000 IU Total
Hide Arm/Group Description Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D Total of all reporting groups
Overall Number of Baseline Participants 64 65 63 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 65 participants 63 participants 192 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
 100.0%
65
 100.0%
63
 100.0%
192
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 65 participants 63 participants 192 participants
27.5  (5.5) 27.4  (4.8) 25.7  (5.5) 26.9  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 65 participants 63 participants 192 participants
Female
64
 100.0%
65
 100.0%
63
 100.0%
192
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Arab Emirates Number Analyzed 64 participants 65 participants 63 participants 192 participants
64 65 63 192
Maternal serum 25 hydroxy Vitamin D (25(OH)D)  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 64 participants 65 participants 63 participants 192 participants
21.5  (13.0) 20.5  (11.9) 19.6  (7.7) 20.7  (11.6)
1.Primary Outcome
Title Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Hide Description 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
Time Frame 29 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis.
Arm/Group Title 400 IU 2000 IU 4000 IU
Hide Arm/Group Description:
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
Overall Number of Participants Analyzed 55 52 55
Mean (Standard Error)
Unit of Measure: nmol/L
Maternal at 12 Weeks 21.5  (1.6) 20.5  (1.5) 19.6  (1.0)
Maternal at 16 Weeks 40.7  (2.1) 53.7  (2.3) 60.7  (3.3)
Maternal at 28 Weeks 53.9  (3.2) 82.3  (4.4) 88.2  (4.2)
Maternal at Delivery 48.2  (3.1) 64.9  (4.0) 89.8  (4.6)
Neonatal at Birth 36.9  (2.8) 48.3  (3.5) 66.1  (3.2)
2.Secondary Outcome
Title Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
Hide Description Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 400 IU 2000 IU 4000 IU
Hide Arm/Group Description:
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
Overall Number of Participants Analyzed 55 52 55
Mean (Standard Deviation)
Unit of Measure: cm
Heel Crown Length 51.9  (2.2) 51.6  (2.8) 50.9  (3.7)
Head Circumference 34.1  (1.4) 34.5  (2.0) 33.9  (2.2)
3.Secondary Outcome
Title Birthweight of Newborn Infant
Hide Description Growth of the Newborn Infant as Measured by Birthweight in grams.
Time Frame Measured at birth.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 400 IU 2000 IU 4000 IU
Hide Arm/Group Description:
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
Overall Number of Participants Analyzed 55 52 55
Mean (Standard Deviation)
Unit of Measure: Grams
3100  (374) 3191  (492) 3103  (639)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 400 IU 2000 IU 4000 IU
Hide Arm/Group Description Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
All-Cause Mortality
400 IU 2000 IU 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
400 IU 2000 IU 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/65 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
400 IU 2000 IU 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/65 (0.00%)   0/63 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Adekunle Dawodu
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-1966
EMail: Adekunle.Dawodu@cchmc.org
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00610688    
Other Study ID Numbers: PA 03-103
First Submitted: December 27, 2007
First Posted: February 8, 2008
Results First Submitted: May 15, 2012
Results First Posted: June 7, 2013
Last Update Posted: June 7, 2013