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Trial record 32 of 43 for:    "multiple sclerosis" AND "vitamin D"

Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina

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ClinicalTrials.gov Identifier: NCT00412087
Recruitment Status : Completed
First Posted : December 15, 2006
Results First Posted : June 10, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Carol Wagner, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Vitamin D Deficiency
Pregnancy
Interventions Drug: cholecalciferol (vitamin D3)
Drug: cholecalciferol
Enrollment 564
Recruitment Details  
Pre-assignment Details 564 women consented to participate in Aim 1 of the study (collection of cross-sectional baseline measures only). Of those 564 women, 265 were enrolled in Aim 2 of the study; only the Aim 2 cohort were randomized to intervention groups and followed through delivery.
Arm/Group Title Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Hide Arm/Group Description

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Period Title: Overall Study
Started 134 131
Completed 72 66
Not Completed 62 65
Arm/Group Title Cholecalciferol 2000 IU Cholecalciferol 4000 IU Total
Hide Arm/Group Description

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Total of all reporting groups
Overall Number of Baseline Participants 134 131 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 131 participants 265 participants
24.4  (5.5) 25.2  (4.8) 24.8  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 131 participants 265 participants
Female
134
 100.0%
131
 100.0%
265
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 25-hydroxyvitamin D at Visit 7
Hide Description 25-hydroxyvitamin D at Visit 7, one month prior to delivery
Time Frame 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Hide Arm/Group Description:

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Overall Number of Participants Analyzed 72 66
Mean (Standard Deviation)
Unit of Measure: ng/mL
36.7  (14.9) 39.8  (12.9)
2.Secondary Outcome
Title Parathyroid Hormone at Visit 7
Hide Description Intact parathyroid hormone at Visit 7, one month prior to delivery
Time Frame 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
There was 1 subject in the 2000 IU group and 3 subjects in the 4000 IU group missing PTH measurements.
Arm/Group Title Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Hide Arm/Group Description:

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Overall Number of Participants Analyzed 71 63
Mean (Standard Deviation)
Unit of Measure: pg/mL
17.3  (8.3) 14.3  (6.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Hide Arm/Group Description

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

All-Cause Mortality
Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/134 (3.73%)      2/131 (1.53%)    
Pregnancy, puerperium and perinatal conditions     
Fetal loss  5/134 (3.73%)  5 2/131 (1.53%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cholecalciferol 2000 IU Cholecalciferol 4000 IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/134 (22.39%)      20/131 (15.27%)    
Pregnancy, puerperium and perinatal conditions     
Complications of Pregnancy  30/134 (22.39%)  30 20/131 (15.27%)  20
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carol Wagner
Organization: Medical University of South Carolina
Phone: 18437922112
EMail: wagnercl@musc.edu
Layout table for additonal information
Responsible Party: Carol Wagner, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00412087     History of Changes
Other Study ID Numbers: HR-16476
First Submitted: December 13, 2006
First Posted: December 15, 2006
Results First Submitted: May 4, 2016
Results First Posted: June 10, 2016
Last Update Posted: July 29, 2016