Establishing the Vitamin D Requirements During Lactation

This study is currently recruiting participants.

Verified by Medical University of South Carolina, December 2006

First Received: December 13, 2006 Last Updated: December 14, 2006 History of Changes

Sponsors and Collaborators:	Medical University of South Carolina National Institutes of Health (NIH)
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00412074

Purpose

The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant

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

MedlinePlus related topics: Breast Feeding

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Establishing the Vitamin D Requirements During Lactation

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

Primary Outcome Measures:

25(OH)D levels for postpartum mother and the breastfeeding infant following for 7 months after delivery; bone mineral density of both mother and infant

Estimated Enrollment:	556
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2010

Detailed Description:

Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to either Group A: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400 IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended practice) and infants of mothers assigned to Groups B or C will recieve placebo. By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored.

Through this study, the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Mother plans to breastfeed exclusively for at least six months
Mother is in good health
Infant is 35 weeks’ gestation or greater
Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).

Exclusion Criteria:

Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant’s feedings during the first six months
Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
Infant is less than 35 weeks’ gestation
Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
Mother has history of hypercalciuria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412074

Contacts

Contact: Carol L Wagner, MD	(843) 792-8829	wagnercl@musc.edu
Contact: Bruce W Hollis, Ph.D	(843) 792-6854	hollisb@musc.edu

Locations

United States, New York
University of Rochester Medical Center	Recruiting
Rochester, New York, United States, 14642
Contact: Cynthia R. Howard, MD, MPH 585-922-3926 cindy.howard@viahealth.org
Principal Investigator: Cynthia R. Howard, MD, MPH
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Carol L. Wagner, MD 843-792-8829 wagnercl@musc.edu
Contact: Bruce W. Hollis, Ph.D 843 792-6854 hollisb@musc.edu
Principal Investigator: Carol L. Wagner, MD

Sponsors and Collaborators

Medical University of South Carolina

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Bruce W. Hollis, Ph.D	Medical University of South Carolina
Principal Investigator:	Carol L. Wagner, MD	Medical University of South Carolina
Study Chair:	Thomas C. Hulsey, Ph.D	Medical University of South Carolina

More Information

No publications provided

Study ID Numbers:	HD047511, 1 RO1 HD047511-01A2, MUSC HR#16536
Study First Received:	December 13, 2006
Last Updated:	December 14, 2006
ClinicalTrials.gov Identifier:	NCT00412074 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

Breastfeeding
Vitamin D
Vitamin D deficiency

Study placed in the following topic categories:

Vitamin D Deficiency
Cholecalciferol
Vitamin D
Malnutrition
Avitaminosis
Vitamins

Nutrition Disorders
Bone Density Conservation Agents
Trace Elements
Micronutrients
Deficiency Diseases

Additional relevant MeSH terms:

Vitamin D Deficiency
Cholecalciferol
Avitaminosis
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

Malnutrition
Vitamin D
Vitamins
Nutrition Disorders
Micronutrients
Deficiency Diseases

ClinicalTrials.gov processed this record on May 07, 2009