Prevention of Vitamin D Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00494104
First received: June 28, 2007
Last updated: December 14, 2012
Last verified: September 2006
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase [ Time Frame: end of winter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494104

Locations
United States, Iowa
MTF, 2501 Crosspark Rd
Coralville, Iowa, United States, 52241-8802
Sponsors and Collaborators
Investigators
Principal Investigator: Ekhard Ziegler, MD University of Iowa
  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 April 23, 2014