Evaluation of Vitamin D Requirements During Pregnancy - Full Text View

Purpose

The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.

Condition	Intervention	Phase
Vitamin D Deficiency	Drug: cholecalciferol (vitamin D3) Drug: cholecalciferol	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Evaluation of Vitamin D Requirements During Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

25(OH)D levels throughout pregnancy and following delivery and bone mineral density of both mother and infant [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Enrollment:	516
Study Start Date:	January 2004
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: cholecalciferol-400 IU Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day	Drug: cholecalciferol (vitamin D3) randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day Drug: cholecalciferol comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy Other Name: vitamin D3
Experimental: cholecalciferol 2000 IU Experimental group receiving 2000 IU total vitamin D3/day.	Drug: cholecalciferol (vitamin D3) randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day Drug: cholecalciferol comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy Other Name: vitamin D3
Experimental: cholecalciferol 4000 IU Experimental group receiving 4000 IU/day cholecalciferol	Drug: cholecalciferol (vitamin D3) randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day Drug: cholecalciferol comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy Other Name: vitamin D3

Detailed Description:

The prevalence of hypovitaminosis D in reproductive aged African-American women occurs at a rate of > 40%. Two factors have contributed to this public health problem: an inadequate DRI for vitamin D and avoidance of sun exposure/use of sunscreen. This startling rate of hypovitaminosis D requires that the DRI for vitamin D in pregnancy be evaluated in a detailed manner. The Cochrane Library (2002) released a report stating that there is insufficient data to evaluate the effects of vitamin D supplementation during pregnancy. Recently, the safety of prolonged supplementation with up to 25x's DRI (10,000 IU/day) was demonstrated in nonpregnant adults. It is essential to determine what dose of vitamin D is required to eliminate hypovitaminosis D during pregnancy and provide the fetus/neonate with adequate vitamin D stores during development and growth, particularly in darkly pigmented individuals. The aim of this research proposal, then, is to determine the efficacy, effectiveness, and safety of maternal vitamin D supplementation (as a function of ethnicity and UV exposure) in the prevention of hypovitaminosis D in the pregnant mother and her fetus/neonate. We hypothesize that darkly pigmented mothers will require substantially higher oral supplementation with vitamin D to eliminate hypovitaminosis D as compared to their Caucasian counterparts. We propose a comprehensive clinical trial to test our hypothesis. Mothers at 12 weeks' gestation will be randomized to one of three vitamin D treatment groups:

Control, 400-,
2,000-, or
4,000 IU/day to be continued throughout pregnancy.

Calcium and vitamin D homeostasis and skeletal remodeling in the mother will be monitored closely throughout the pregnancy. Bone density of the mother will be measured at 12 weeks' gestation and one-month postpartum. Follow-up growth and skeletal integrity assessments of the infant will be performed at birth, 1, 6 and 12 months stratified by infant feeding regime. Through these proposed studies, the prevalence of hypovitaminosis D among mothers, their developing fetuses and neonates, and the utility of maternal therapeutic intervention with vitamin D for both mother and fetus/infant will be assessed.

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women who are within the ages of 16-45 years
In good general health
Less than 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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292591

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Bruce W. Hollis, Ph.D.	Medical University of South Carolina
Principal Investigator:	Carol L. Wagner, M.D.	Medical University of South Carolina
Study Director:	Donna Johnson, M.D.	Medical University of South Carolina
Study Chair:	Thomas C. Hulsey, Sc.D.	Medical University of South Carolina

More Information

Publications:

Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum in: J Bone Miner Res. 2011 Dec; 26(12):3001.

Hollis BW, Wagner CL. Vitamin D requirements and supplementation during pregnancy. Curr Opin Endocrinol Diabetes Obes. 2011 Dec;18(6):371-5.

Hollis BW. Circulating 25-hydroxyvitamin D levels indicative of vitamin D sufficiency: implications for establishing a new effective dietary intake recommendation for vitamin D. J Nutr. 2005 Feb;135(2):317-22. Review.

Hollis BW, Wagner CL. Normal serum vitamin D levels. N Engl J Med. 2005 Feb 3;352(5):515-6; author reply 515-6. No abstract available.

Responsible Party:	Carol Wagner, Professor of Pediatrics, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00292591 History of Changes
Other Study ID Numbers:	R01 HD043921, 5R01HD043921
Study First Received:	February 15, 2006
Last Updated:	April 25, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

vitamin D
cholecalciferol
pregnancy
bone mineral density

Additional relevant MeSH terms:

Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D

Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013