Establishing the Vitamin D Requirements During Lactation

Phase 3

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: 6400 IU Vitamin D3 (cholecalciferol); Drug: 400 IU Vitamin D3 (cholecalciferol); Drug: 2400 IU Vitamin D3 (cholecalciferol)

• Registration Number: NCT00412074
• Lead Sponsor: Medical University of South Carolina

Brief 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

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2016-04-27
• Results First Submitted QC: 2016-04-27
• Results First Posted: 2016-06-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6400 IU vitamin D3 (cholecalciferol)	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
Control 400 IU vitamin D3	400 IU Vitamin D3 (cholecalciferol)	400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
2400 IU vitamin D3 (cholecalciferol)	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

Primary Outcome Measures

Name	Time	Method
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery	to 7 months postpartum

Secondary Outcome Measures

Name	Time	Method
Infant Health Status - Vitamin D Deficiency	to 7 months of age	Percentage of infants with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7
Maternal Health Status - Vitamin D Deficiency	to 7 months postpartum	Percentage of subjects with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7

Trial Locations

Locations (2)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States