Establishing the Vitamin D Requirements During Lactation
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 6/6/2018 |
| Start Date: | August 2006 |
| End Date: | October 2012 |
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
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
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.
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.
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
We found this trial at
2
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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