Prevention of Vitamin D Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00494104
First received: June 28, 2007
Last updated: December 14, 2012
Last verified: September 2006

June 28, 2007
December 14, 2012
September 2006
September 2011   (final data collection date for primary outcome measure)
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase [ Time Frame: end of winter ] [ Designated as safety issue: No ]
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase [ Time Frame: end of winter ]
Complete list of historical versions of study NCT00494104 on ClinicalTrials.gov Archive Site
whole body mineral content by DEXA [ Time Frame: end of winter ] [ Designated as safety issue: No ]
whole body mineral content by DEXA [ Time Frame: end of winter ]
Not Provided
Not Provided
 
Prevention of Vitamin D Deficiency
Prevention of Vitamin D Deficiency in Breastfed Infants

Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency

It is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin D deficiency, especially if their skin is darkly pigmented. The study by the PI (Pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin D deficiency. During winter (December - April) a full 78% of infants were vitamin D deficient if they did not receive vitamin D from an external source. Very few breastfed babies are currently receiving supplemental vitamin D. The recommended dose is 200 IU/day. However, there are questions about the adequacy of this dose of vitamin D for the prevention of vitamin D deficiency. The present trial is designed to determine whether a dose of 200 IU/day is effective or whether doses of 400 IU/day, 600 IU/day or 800 IU/day are required to prevent vitamin D deficiency reliably.

The trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or 600 IU/day or 800 IU/day from 1 to 9 months of age. There will not be a placebo control group. Infants will be followed through 12 months of age. Normal term infants (birth weight >2500 g) who are born in June through November will be enrolled and randomized at 1 month of age. They will visit the study center at monthly intervals and will have capillary blood drawn at select ages. At 2 months and again in March or April whole body mineral content will be determined by DEXA. Infants will not be permitted to receive formula until 9 months of age. They may receive complementary foods beginning at 4 months of age. Vitamin D supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. Study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between March and May 15. Blood parameters include 25-OHD, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, N-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Vitamin D Deficiency
Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
Infants receive daily 0.5 ml of code labeled supplement
  • Active Comparator: 200 IU/day Vitamin D
    200 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
  • Experimental: 400 IU/day Vitamin D
    400 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
  • Experimental: 600 IU/day Vitamin D
    600 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
  • Experimental: 800 IU/day Vitamin D
    800 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatr Res. 2014 Aug;76(2):177-83. doi: 10.1038/pr.2014.76. Epub 2014 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term infant
  • No major congenital malformations
  • Less than one month old
  • Breastfed, no other foods

Exclusion Criteria:

  • Formula feeding
  • Premature birth
Both
up to 5 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00494104
R01HD048870, R01HD048870
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Ekhard Ziegler, MD University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP