Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy

January 28, 2016 updated by: Martha Blackford, PharmD, Akron Children's Hospital

Vitamin D Serum Concentrations and Vitamin D Supplementation in Children and Young Adults With Cerebral Palsy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severely cognitively impaired, non-mobile children and young adults who are residents at long-term care facility

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Vitamin D supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum vitamin D concentrations
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Longitudinal Vitamin D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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