Prevention of Vitamin D Deficiency
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

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.
    

Intervention name(s): Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
Intervention type(s): Dietary Supplement
Intervention description(s): Infants receive daily 0.5 ml of code labeled supplement
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: vitamin D deficiency; breastfed infant; northern latitude; infant; breastfed; winter; vitamin D status