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

NCT00502866 | Completed

• 1 other identifier: R03HS016029-01
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Rickets

Keywords

breastfeeding; vitamin D supplementation; rickets

Study Arms (1)

breastfed children

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

Eligibility Criteria

• Age: 6 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

breastfed children

You may qualify if:

• 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

You may not qualify if:

• Formula fed
• Significant formula supplementation

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ): lead
• University of Washington: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

Location

Related Publications (1)

• Taylor JA, Richter M, Done S, Feldman KW. The utility of alkaline phosphatase measurement as a screening test for rickets in breast-fed infants and toddlers: a study from the puget sound pediatric research network. Clin Pediatr (Phila). 2010 Dec;49(12):1103-10. doi: 10.1177/0009922810376993. Epub 2010 Aug 19.

  PMID: 20724326 RESULT

MeSH Terms

Conditions

Rickets; Breast Feeding

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Feeding Behavior; Behavior

Study Officials

• James A Taylor, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 18, 2007
• Study Start: June 1, 2006
• Study Completion: June 1, 2008
• Last Updated: January 8, 2014

Record last verified: 2006-10

Locations

US (1)