Expired Study
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Cincinnati, Ohio 45229


Purpose:

The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.


Study summary:

Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.


Criteria:

Inclusion Criteria: - Women who are within the ages of 18-45 years - In good general health - 12 weeks pregnant (based on last menstrual period) Exclusion Criteria: - Mothers with preexisting type I or type II diabetes - Mothers with preexisting hypertension - Mothers with preexisting parathyroid disease or uncontrolled thyroid disease - Mothers with multiple fetuses (e.g., twins, triplets, etc.)


Study is Available At:


Original ID:

PA 03-103


NCT ID:

NCT00610688


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Medical Center, Cincinnati


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board
  • United Arab Emirates: General Authority for Health Services for Abu Dhabi


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

192


Enrollment Type:

Actual


Overall Contact Information

Official Name:Adekunle Dawodu, MBBS
Principal Investigator
Children's Hospital Medical Center, Cincinnati

Study Dates

Start Date:January 2008
Completion Date:April 2012
Completion Type:Actual
Primary Completion Date:June 2011
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 5, 2013
First Received Date:December 27, 2007
First Results Date:May 15, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Birthweight of Newborn Infant
Time Frame:Measured at birth.
Safety Issues:False
Description:Growth of the Newborn Infant as Measured by Birthweight in grams.
Outcome Type:Secondary Outcome
Measure:Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
Time Frame:At delivery
Safety Issues:False
Description:Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth
Outcome Type:Primary Outcome
Measure:Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
Time Frame:29 weeks
Safety Issues:False
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

Study Interventions

Intervention Type:Drug
Name:Prenatal Vitamin
Description:Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Arm Name:Prenatal Vitamin D3
Intervention Type:Drug
Name:Cholecalciferol (Vitamin D3)
Description:Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
Arm Name:2
Intervention Type:Drug
Name:Cholecalciferol (Vitamin D3)
Description:Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Arm Name:3

Study Arms

Study Arm Type:Experimental
Arm Name:3
Description:Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
Study Arm Type:Experimental
Arm Name:2
Description:Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
Study Arm Type:Placebo Comparator
Arm Name:Prenatal Vitamin D3
Description:Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Medical Center, Cincinnati
Agency Class:Other
Agency Type:Collaborator
Agency Name:United Arab Emirates University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. No abstract available.
PMID:17715433
Reference Type:Reference
Citation:Saadi HF, Dawodu A, Afandi BO, Zayed R, Benedict S, Nagelkerke N. Efficacy of daily and monthly high-dose calciferol in vitamin D-deficient nulliparous and lactating women. Am J Clin Nutr. 2007 Jun;85(6):1565-71.
PMID:17556694
Reference Type:Reference
Citation:Dawodu A, Agarwal M, Hossain M, Kochiyil J, Zayed R. Hypovitaminosis D and vitamin D deficiency in exclusively breast-feeding infants and their mothers in summer: a justification for vitamin D supplementation of breast-feeding infants. J Pediatr. 2003 Feb;142(2):169-73.
PMID:12584539
Reference Type:Reference
Citation:Dawodu A, Agarwal M, Sankarankutty M, Hardy D, Kochiyil J, Badrinath P. Higher prevalence of vitamin D deficiency in mothers of rachitic than nonrachitic children. J Pediatr. 2005 Jul;147(1):109-11.
PMID:16027707

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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