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

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00502866
First received: July 17, 2007
Last updated: January 7, 2014
Last verified: October 2006
  Purpose

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
Rickets

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Feasibility of Assessing the Prevalence of Rickets in Children

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Enrollment: 246
Study Start Date: June 2006
Study Completion Date: June 2008
Groups/Cohorts
breastfed children
children, 6-15 months old, predominately breastfed for at least 6 months without supplemental vitamin D

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.

  Eligibility

Ages Eligible for Study:   6 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

breastfed children

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502866

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98115
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: James A Taylor, MD University of Washington
  More Information

Publications:
Responsible Party: Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00502866     History of Changes
Other Study ID Numbers: R03 HS016029-01, R03 HS016029-01
Study First Received: July 17, 2007
Last Updated: January 7, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 20, 2014