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

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

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 Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3); Drug: Cholecalciferol (Vitamin D3)

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi
    • Al-Ain, Abu Dhabi, United Arab Emirates
      • United Arab Emirated Unitersity
• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Prenatal Vitamin D3; Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D	Drug: Prenatal Vitamin; Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Experimental: 2; Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)	Drug: Prenatal Vitamin; Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery; Drug: Cholecalciferol (Vitamin D3); Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery; Drug: Cholecalciferol (Vitamin D3); Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Experimental: 3; Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).	Drug: Prenatal Vitamin; Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery; Drug: Cholecalciferol (Vitamin D3); Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery; Drug: Cholecalciferol (Vitamin D3); Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Birthweight of Newborn Infant	Growth of the Newborn Infant as Measured by Birthweight in grams.	Measured at birth.

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Thrasher Research Fund; United Arab Emirates University
• Investigators: Principal Investigator: Adekunle Dawodu, MBBS, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Hussein F Saadi, MD, United Arab Emirates University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 27, 2007
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 2008-0931