Prevention of Vitamin D Deficiency
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention |
|---|---|
|
Vitamin D Deficiency |
Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Prevention of Vitamin D Deficiency in Breastfed Infants |
- Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase [ Time Frame: end of winter ] [ Designated as safety issue: No ]
- whole body mineral content by DEXA [ Time Frame: end of winter ] [ Designated as safety issue: No ]
| Enrollment: | 398 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 200 IU/day Vitamin D
200 IU/day Vitamin D
|
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
|
|
Experimental: 400 IU/day Vitamin D
400 IU/day Vitamin D
|
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
|
|
Experimental: 600 IU/day Vitamin D
600 IU/day Vitamin D
|
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
|
|
Experimental: 800 IU/day Vitamin D
800 IU/day Vitamin D
|
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
|
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| Ages Eligible for Study: | up to 5 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Term infant
- No major congenital malformations
- Less than one month old
- Breastfed, no other foods
Exclusion Criteria:
- Formula feeding
- Premature birth
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00494104 History of Changes |
| Other Study ID Numbers: | R01HD048870, R01HD048870 |
| Study First Received: | June 28, 2007 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
vitamin D deficiency breastfed infant northern latitude infant |
breastfed winter vitamin D status |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013