Establishing the Vitamin D Requirements During Lactation

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 3

Conditions: Vitamin D Deficiency

Treatments: Drug: 2400 IU Vitamin D3 (cholecalciferol); Drug: 400 IU Vitamin D3 (cholecalciferol); Drug: 6400 IU Vitamin D3 (cholecalciferol)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00412074

HD047511

R01HD047511 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 460 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

460 participants in 3 patient groups

Control 400 IU vitamin D3

Active Comparator group

Description:

400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad

Treatment:

Drug: 400 IU Vitamin D3 (cholecalciferol)

2400 IU vitamin D3 (cholecalciferol)

Experimental group

Description:

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

Treatment:

Drug: 2400 IU Vitamin D3 (cholecalciferol)

6400 IU vitamin D3 (cholecalciferol)

Experimental group

Description:

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

Treatment:

Drug: 6400 IU Vitamin D3 (cholecalciferol)