Prevention of Vitamin D Deficiency

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day

Study type: Interventional

Funder types: NIH

Identifiers

NCT00494104

R01HD048870 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 398 patients

Sex: All

Ages: 3 to 5 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Formula feeding
• Premature birth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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398 participants in 4 patient groups

200 IU/day Vitamin D

Active Comparator group

Description:

200 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day

400 IU/day Vitamin D

Experimental group

Description:

400 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day

600 IU/day Vitamin D

Experimental group

Description:

600 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day

800 IU/day Vitamin D

Experimental group

Description:

800 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day