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Completed

NCT Number: NCT00412074

Establishing the Vitamin D Requirements During Lactation

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

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Breast Feeding Deficiency Diseases Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Rochester Medical Center, Rochester, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

400 IU Vitamin D3 (cholecalciferol)

Drug

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)

Drug

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)

Drug

6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant

Primary outcomes

  1. 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery

    Time frame: to 7 months postpartum

Secondary outcomes

  1. Maternal Health Status - Vitamin D Deficiency

    Time frame: to 7 months postpartum

    Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7

  2. Infant Health Status - Vitamin D Deficiency

    Time frame: to 7 months of age

    Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2006
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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