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Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01926808
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Martha Blackford, PharmD, Akron Children's Hospital

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
Vitamin D Deficiency

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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 : June 2013
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
Vitamin D supplementation



Primary Outcome Measures :
  1. Change in serum vitamin D concentrations [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severely cognitively impaired, non-mobile children and young adults who are residents at long-term care facility
Criteria

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

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Responsible Party: Martha Blackford, PharmD, PharmD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01926808     History of Changes
Other Study ID Numbers: Longitudinal Vitamin D
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Cerebral Palsy
Vitamin D Deficiency
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents