Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502866
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
2007-07-17
Brief Title:
Study to Assess the Use of a Simple Lab Test to Screen for Rickets in Children
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
The Feasibility of Assessing the Prevalence of Rickets in Children
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont 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 didnt routinely receive vitamin D are eligible for alkaline phosphatase levels We postulate that most breastfed babies dont 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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03HS016029-01 | AHRQ | None | httpsreporternihgovquickSearchR03HS016029-01 |