NCT03258086

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

August 20, 2017

Last Update Submit

January 8, 2018

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Assessment of vitamin D level (ng/ml)

    24 hours

Study Arms (1)

Blood sample

EXPERIMENTAL

2ml blood sample of of blood will be taken for assessment of vitamin D

Diagnostic Test: blood sample test

Interventions

blood sample testDIAGNOSTIC_TEST

blood sample will be taken from all diabetic children for assessment of vitamin D level

Blood sample

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age (5 years - 15 years ).
  • Type 1 diabetes patients.

You may not qualify if:

  • Patients aged more than 15 years, less than 2 years.
  • Type 2 diabetes.
  • Neonatal diabetes.
  • Patients with any complications from diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 20, 2017

First Posted

August 23, 2017

Study Start

November 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)