Establishing the Vitamin D Requirements During Lactation

Vitamin D Deficiency Clinical Trial

Official title:

Establishing the Vitamin D Requirements During Lactation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412074
• Other study ID #: HD047511
• Secondary ID: R01HD047511
• Status: Completed
• Phase: Phase 3
• Start date: August 2006
• Est. completion date: October 2012

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery		to 7 months postpartum
Secondary	Maternal Health Status - Vitamin D Deficiency	Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7	to 7 months postpartum
Secondary	Infant Health Status - Vitamin D Deficiency	Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7	to 7 months of age