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

This study is currently recruiting participants.
Study NCT00502866.   Last updated on July 17, 2007.   Information provided by Agency for Healthcare Research and Quality (AHRQ)

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Descriptive Information Fields
Brief Title  Study to Assess the Use of a Simple Lab Test to Screen for Rickets in Children
Official Title  The Feasibility of Assessing the Prevalence of Rickets in Children
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.

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 Phase
Study Type  Observational
Study Design  Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Rickets
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  300
Start Date  June 2006
Completion Date July 2007
Eligibility Criteria 

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
Gender Both
Ages 6 Months to 15 Months
Accepts Healthy Volunteers Yes
Contacts ††
Contact: James A Taylor, MD     (206) 616-1206     uncjat@u.washington.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00502866
Organization ID R03 HS016029-01
Secondary IDs †† R03 HS016029-01
Study Sponsor  Agency for Healthcare Research and Quality (AHRQ)
Collaborators †† University of Washington
Investigators 
Principal Investigator:     James A Taylor, MD     University of Washington    
Information Provided By Agency for Healthcare Research and Quality (AHRQ)
Verification Date October 2006
First Received Date  July 17, 2007
Last Updated Date July 17, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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