Back to results

Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants (PA 03-103)

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Prenatal Vitamin

Cholecalciferol (Vitamin D3)

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

Cincinnati Children's Hospital Medical Center
United Arab Emirated Unitersity

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Prenatal Vitamin D3

Arm Description

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Outcomes

Primary Outcome Measures

Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement

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

Secondary Outcome Measures

Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth

Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth

Birthweight of Newborn Infant

Growth of the Newborn Infant as Measured by Birthweight in grams.

Full Information

NCT ID

NCT00610688

First Posted

December 27, 2007

Last Updated

September 28, 2021

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

United Arab Emirates University, Thrasher Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT00610688

Brief Title

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

Acronym

PA 03-103

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

United Arab Emirates University, Thrasher Research Fund

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prenatal Vitamin D3

Arm Type

Placebo Comparator

Arm Description

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D

Arm Title

Arm Type

Experimental

Arm Description

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)

Arm Title

Arm Type

Experimental

Arm Description

Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

Intervention Type

Drug

Intervention Name(s)

Prenatal Vitamin

Intervention Description

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol (Vitamin D3)

Intervention Description

Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol (Vitamin D3)

Intervention Description

Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Primary Outcome Measure Information:

Title

Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement

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

12, 16, 28 weeks and at maternal delivery and neonatal birth

Secondary Outcome Measure Information:

Title

Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth

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

Title

Birthweight of Newborn Infant

Description

Growth of the Newborn Infant as Measured by Birthweight in grams.

Time Frame

Measured at birth.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adekunle Dawodu, MBBS

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hussein F Saadi, MD

Organizational Affiliation

United Arab Emirates University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

United Arab Emirated Unitersity

City

Al-Ain

State/Province

Abu Dhabi

Country

United Arab Emirates

12. IPD Sharing Statement

Citations:

PubMed Identifier

16027707

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. doi: 10.1016/j.jpeds.2005.03.001.

Results Reference

background

PubMed Identifier

12584539

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. doi: 10.1067/mpd.2003.63.

Results Reference

background

PubMed Identifier

17556694

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. doi: 10.1093/ajcn/85.6.1565.

Results Reference

background

PubMed Identifier

17715433

Citation

Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. doi: 10.1136/adc.2007.122689.

Results Reference

background

PubMed Identifier

22666547

Citation

Wagner CL, Taylor SN, Dawodu A, Johnson DD, Hollis BW. Vitamin D and its role during pregnancy in attaining optimal health of mother and fetus. Nutrients. 2012 Mar;4(3):208-30. doi: 10.3390/nu4030208. Epub 2012 Mar 21.

Results Reference

background

PubMed Identifier

22585912

Citation

Dawodu A, Tsang RC. Maternal vitamin D status: effect on milk vitamin D content and vitamin D status of breastfeeding infants. Adv Nutr. 2012 May 1;3(3):353-61. doi: 10.3945/an.111.000950.

Results Reference

background

PubMed Identifier

22525442

Citation

Dawodu A, Wagner CL. Prevention of vitamin D deficiency in mothers and infants worldwide - a paradigm shift. Paediatr Int Child Health. 2012 Feb;32(1):3-13. doi: 10.1179/1465328111Y.0000000024.

Results Reference

background

PubMed Identifier

23559082

Citation

Dawodu A, Saadi HF, Bekdache G, Javed Y, Altaye M, Hollis BW. Randomized controlled trial (RCT) of vitamin D supplementation in pregnancy in a population with endemic vitamin D deficiency. J Clin Endocrinol Metab. 2013 Jun;98(6):2337-46. doi: 10.1210/jc.2013-1154. Epub 2013 Apr 4.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs