Establishing the Vitamin D Requirements During Lactation

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carol Wagner, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00412074
First received: December 13, 2006
Last updated: June 10, 2016
Last verified: June 2016
  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: 400 IU Vitamin D3 (cholecalciferol)
Drug: 2400 IU Vitamin D3 (cholecalciferol)
Drug: 6400 IU Vitamin D3 (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: Treatment
Official Title: Establishing the Vitamin D Requirements During Lactation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery [ Time Frame: to 7 months postpartum ] [ Designated as safety issue: Yes ]

Enrollment: 460
Study Start Date: August 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control 400 IU vitamin D3
400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
Drug: 400 IU Vitamin D3 (cholecalciferol)
400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
Experimental: 2400 IU vitamin D3 (cholecalciferol)
2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Drug: 2400 IU Vitamin D3 (cholecalciferol)
2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
Experimental: 6400 IU vitamin D3 (cholecalciferol)
6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Drug: 6400 IU Vitamin D3 (cholecalciferol)
6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant

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 receive placebo. On 2/5/2009, the protocol was amended and the Group B arm was dropped; infants of active subjects randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through study completion. Newly enrolled subjects after this date were randomized to Group A or Group C only.

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
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, MD Medical University of South Carolina
Study Chair: Thomas C. Hulsey, Ph.D Medical University of South Carolina
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carol Wagner, Professor of Pediatrics, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00412074     History of Changes
Other Study ID Numbers: HD047511  R01HD047511 
Study First Received: December 13, 2006
Results First Received: April 27, 2016
Last Updated: June 10, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Breastfeeding
Vitamin D
Vitamin D deficiency

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 30, 2016