Study to Assess the Use of a Simple Lab Test to Screen for Rickets in Children

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. Identifier: NCT00502866
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : January 8, 2014
University of Washington
Information provided by (Responsible Party):
Agency for Healthcare Research and Quality (AHRQ)

Brief Summary:
Some experts recommend that all breastfed babies receive supplemental vitamin D. The purpose of this study is to determine the rate of vitamin D use in breastfed babies, the recommendations of pediatricians regarding vitamin D, and the impact on these recommendations on parental choice of vitamin D. In addition, in preparation for a large study to see how many breastfed children who don't receive supplemental vitamin D have rickets, in this study we will determine if a simple blood test, an alkaline phosphatase level, could be used to screen for rickets. Parents of children 6-23 months old are eligible to complete feeding surveys and children 6-15 months old who were breastfed for at least the first six months of life and didn't routinely receive vitamin D are eligible for alkaline phosphatase levels. We postulate that most breastfed babies don't receive supplemental vitamin D, and that alkaline phosphatase levels will only be abnormal in a few babies who will have evidence on x-ray of rickets.

Condition or disease

Detailed Description:
The Puget Sound Pediatric Research Network (PSPRN) is a practice-based research network of pediatricians in the Puget Sound area and at the University of Washington and Children's Hospital and Regional Medical Center. The network has extensive experience in conducting large studies on contentious issues that are pertinent to children, their parents, and primary care providers. In 2004, vitamin D supplementation was recommended for all exclusively breastfed infants. This recommendation was based on sporadic reports over the last 30 years of vitamin D deficient rickets in infants and toddlers who have been exclusively breastfed. The recommendation has been controversial because it might undermine efforts to promote breastfeeding, and because the prevalence of rickets in these patients is unknown. PSPRN proposes to conduct a preliminary study to determine the feasibility of a larger planned project by the network to determine the prevalence of rickets in breastfed infants and toddlers who do not receive supplemental vitamin D. Systematic surveys will be conducted in PSPRN practices to determine current levels and trends in vitamin D supplementation. Current practices of PSPRN pediatricians regarding supplementation, and their effect on parents, will also be assessed. The utility of a serum alkaline phosphatase level as a screening test for vitamin D deficient rickets will be determined in the proposed study by obtaining levels on approximately 300 patients, 6-15 months old, seen by PSPRN practitioners, who have been breastfed. In addition to assessing possible methodologies for the larger project, the preliminary study is designed to yield standalone results with important implications.

Study Type : Observational
Actual Enrollment : 246 participants
Time Perspective: Cross-Sectional
Official Title: The Feasibility of Assessing the Prevalence of Rickets in Children
Study Start Date : June 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

breastfed children
children, 6-15 months old, predominately breastfed for at least 6 months without supplemental vitamin D

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
breastfed children

Inclusion Criteria:

  • Predominantly breastfed for first 6 months of life
  • No routine use of vitamin D during first six months of life
  • Singleton birth
  • Birth at > 35 weeks gestation

Exclusion Criteria:

  • Formula fed
  • Significant formula supplementation

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 identifier (NCT number): NCT00502866

United States, Washington
University of Washington
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
University of Washington
Principal Investigator: James A Taylor, MD University of Washington

Publications of Results:
Responsible Party: Agency for Healthcare Research and Quality (AHRQ) Identifier: NCT00502866     History of Changes
Other Study ID Numbers: R03HS016029-01 ( U.S. AHRQ Grant/Contract )
R03HS016029-01 ( U.S. AHRQ Grant/Contract )
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: October 2006

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
vitamin D supplementation

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders