NCT00494104

Prevention of Vitamin D Deficiency

Prevention of Vitamin D Deficiency in Breastfed Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 3 Weeks – 5 Weeks
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2007-06-29
• Last updated: 2012-12-18

Locations

1 site across 1 country: United States