We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Vitamin D Deficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494104
First Posted: June 29, 2007
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 ]

Secondary Outcome Measures:
  • whole body mineral content by DEXA [ Time Frame: end of winter ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494104


Locations
United States, Iowa
MTF, 2501 Crosspark Rd
Coralville, Iowa, United States, 52241-8802
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Ekhard Ziegler, MD University of Iowa
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2007
First Posted: June 29, 2007
Last Update Posted: December 18, 2012
Last Verified: September 2006

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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents