Back to resultsVitamin D in Diabetic Children
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
blood sample test
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- Age (5 years - 15 years ).
- Type 1 diabetes patients.
Exclusion Criteria:
- Patients aged more than 15 years, less than 2 years.
- Type 2 diabetes.
- Neonatal diabetes.
- Patients with any complications from diabetes.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood sample
Arm Description
2ml blood sample of of blood will be taken for assessment of vitamin D
Outcomes
Primary Outcome Measures
Assessment of vitamin D level (ng/ml)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03258086
Brief Title
Vitamin D in Diabetic Children
Official Title
Assessment of Vitamin D in Children With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back, or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.
Vitamin D supplement is recommended in all infants until enough formula, milk, or other food sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type 1 diabetes is an autoimmune disease, and the self immune system plays a central role in the destruction of the beta cell of pancrease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood sample
Arm Type
Experimental
Arm Description
2ml blood sample of of blood will be taken for assessment of vitamin D
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sample test
Intervention Description
blood sample will be taken from all diabetic children for assessment of vitamin D level
Primary Outcome Measure Information:
Title
Assessment of vitamin D level (ng/ml)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age (5 years - 15 years ).
Type 1 diabetes patients.
Exclusion Criteria:
Patients aged more than 15 years, less than 2 years.
Type 2 diabetes.
Neonatal diabetes.
Patients with any complications from diabetes.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vitamin D in Diabetic Children
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