Clinical trial NCT00494104: Prevention of Vitamin D Deficiency
Official title: Prevention of Vitamin D Deficiency in Breastfed Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: vitamin D deficiency
breastfed infant
northern latitude
infant
breastfed
winter
vitamin D status
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-06-29
Enrollment: 398
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Formula feeding
* Premature birth

Primary outcomes:
measure: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase
timeFrame: end of winter
Secondary outcomes:
measure: whole body mineral content by DEXA
timeFrame: end of winter
Other outcomes:
Locations:
city: Coralville
country: United States
facility: MTF, 2501 Crosspark Rd
state: Iowa
Study officials:
affiliation: University of Iowa
name: Ekhard Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.