Establishing the Vitamin D Requirements During Lactation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Establishing the Vitamin D Requirements During Lactation

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: 400 IU Vitamin D3 (cholecalciferol)
* Drug: 2400 IU Vitamin D3 (cholecalciferol)
* Drug: 6400 IU Vitamin D3 (cholecalciferol)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control 400 IU vitamin D3<br>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)<br>* 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant<br>|
| Experimental: 2400 IU vitamin D3 (cholecalciferol)<br>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)<br>* 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant<br>|
| Experimental: 6400 IU vitamin D3 (cholecalciferol)<br>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)<br>* 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery |  | to 7 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Vitamin D, Vitamin D deficiency