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

NCT00610688 | Completed Phase 3 Results DMC

• 1 other identifier: 2008-0931
• Study Type: interventional
• Target: 192
• Locations: 2 countries
• Sites: 2

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  At delivery

• Birthweight of Newborn Infant

  Measured at birth.

Study Arms (3)

Prenatal Vitamin D3

PLACEBO COMPARATOR

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

Drug: Prenatal Vitamin

2

EXPERIMENTAL

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

Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3)

3

EXPERIMENTAL

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

Drug: Prenatal Vitamin; Drug: Cholecalciferol (Vitamin D3)

Interventions

Prenatal Vitamin DRUG

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

2; 3; Prenatal Vitamin D3

Cholecalciferol (Vitamin D3) DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who are within the ages of 18-45 years
• In good general health
• weeks pregnant (based on last menstrual period)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• United Arab Emirates University: collaborator
• Thrasher Research Fund: collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

United Arab Emirated Unitersity

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Location

Related Publications (9)

• 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.

  PMID: 16027707 BACKGROUND

• 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.

  PMID: 12584539 BACKGROUND

• 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.

  PMID: 17556694 BACKGROUND

• 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.

  PMID: 17715433 BACKGROUND

• 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.

  PMID: 22666547 BACKGROUND

• 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.

  PMID: 22585912 BACKGROUND

• 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.

  PMID: 22525442 BACKGROUND

• Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

  PMID: 39077939 DERIVED

• 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.

  PMID: 23559082 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Prenatal Care; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Adekunle Dawodu
• Organization: Cincinnati Children's Hospital Medical Center

Adekunle.Dawodu@cchmc.org

513-636-1966

Study Officials

• Adekunle Dawodu, MBBS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Hussein F Saadi, MD

  United Arab Emirates University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: February 8, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: April 1, 2012
• Last Updated: October 19, 2021
• Results First Posted: June 7, 2013

Record last verified: 2021-09

Locations

AE (1); US (1)