NCT01926808

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

August 19, 2013

Last Update Submit

January 28, 2016

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in serum vitamin D concentrations

    5 years

Study Arms (1)

Vitamin D supplementation

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01