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Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy

Sponsor
Akron Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01926808
Collaborator
(none)
115
Enrollment

Study Details

Study Description

Brief Summary

The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with Vitamin D levels, measure affects of seizure medications on levels as well as pathologic fractures and bone density in severely cognitively impaired, non-mobile children and adolescents with CP.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    115 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Vitamin D Serum Concentrations and Vitamin D Supplementation in Children and Young Adults With Cerebral Palsy
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Vitamin D supplementation

    Outcome Measures

    Primary Outcome Measures

    1. Change in serum vitamin D concentrations [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Recorded vitamin D supplementation dose (i.e. prescribed diet and any additional sources of vitamin D) with at least two serum vitamin D concentrations recorded in the medical chart from January 1, 2008 to June 30, 2013.

    • Resident of HLCCD since 2008

    Exclusion Criteria:

    • No vitamin D levels recorded.

    • History of hyperthyroidism or parathyroid pathology.

    • Short gut syndrome that requires TPN.

    • Poor medical documentation.

    • Heritable disorders that affect vitamin D levels such as Pseudovitamin D deficiency rickets, Vitamin D resistant rickets, autosomal dominant hypophosphatemic rickets and X-linked hypophosphatemic rickets

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Akron Children's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martha Blackford, PharmD, PharmD, Akron Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01926808
    Other Study ID Numbers:
    • Longitudinal Vitamin D
    First Posted:
    Aug 21, 2013
    Last Update Posted:
    Jan 29, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Cerebral Palsy
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Jan 29, 2016