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

Vitamin D Deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610688
• Other study ID #: 2008-0931
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: April 2012

Study information

• Verified date: September 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: April 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
• Cholecalciferol (Vitamin D3)
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
• Cholecalciferol (Vitamin D3)
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Locations

Country	Name	City	State
United Arab Emirates	United Arab Emirated Unitersity	Al-Ain	Abu Dhabi
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Thrasher Research Fund, United Arab Emirates University

Countries where clinical trial is conducted

United States,  United Arab Emirates, 

References & Publications (7)

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. — View 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. — View 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. Review. — View Citation

Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12, 16, 28 weeks and at maternal delivery and neonatal birth
Secondary	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	At delivery
Secondary	Birthweight of Newborn Infant	Growth of the Newborn Infant as Measured by Birthweight in grams.	Measured at birth.