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Evaluation the effect of vitamin D on insulin resistance in overweight and obese children with vitamin D deficiency and insulin resistance between age 5 and 15 years old

Protocol summary

Summary
Objective: In this clinical trial the effect of vitamin D supplementation on insulin resistance will be evaluated. Design: The sample included 62 children 5-15 years old who are obese and overweight presenting to pediatric endocrinology clinic. Design: Within the first visit, Height, weight, BMI, BP, and the maturational status are evaluated. Serum levels of vitamin D, Fasting insulin , 10 hours fasting of lipid profile, Fasting plasma glucose is measured. Intervention: In the second phase, patients with insufficient levels of vitamin D or vitamin D deficiency are treated with 50,000 IU of vitamin D Pearl 10 per week to 10 weeks and again, after 2 months from the end of treatment, Serum levels of vitamin D, Fasting plasma glucose and fasting insulin for the effect of vitamin D on insulin resistance will be evaluated. Participants including major eligibility criteria: If obesity is due to syndromic disorder or hypothyroidy or patient taking vitamin D the last 6 months are excluded. Main outcome measures: Insulin resistance and vitamin D deficiency.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121811799N1
Registration date: 2013-05-05, 1392/02/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-05, 1392/02/15
Registrant information
Name
Zahra Alian
Name of organization / entity
Sciences Hamedan University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0063
Email address
z.alian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistant Hamedan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of vitamin D on insulin resistance in overweight and obese children with vitamin D deficiency and insulin resistance between age 5 and 15 years old
Public title
Effect of vitamin D on insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-All children with overweight and obesity, between the ages of 5 and 15 years 2-No previous treatment with vitamin D. Exclusion criteria: 1- Obesity with other causes (syndromic disorder,genetic defect,underlying disease) 2-Presence of comorbidities (hypothyroidy,...) 3- Lack of patient cooperation 4-Previous treatment with vitamin D.
Age
From 5 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sciences Hamedan University of Medical, Ethics Committee
Street address
Ethics Committee, School of Medicine, Shahid Fahmide Street
City
Hamedan
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
3489-9-35-16-پ-د

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E65-ٍE66-E
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Fasting Insulin
Timepoint
Before intervention, 2 Months after the intervention
Method of measurement
ng/dl,ECL method

Secondary outcomes

1

Description
Diabetes
Timepoint
Before intervention, 2 Months after the intervention
Method of measurement
Fasting Blood Sugar,Chyme Enzyme method

2

Description
Obesity
Timepoint
Before intervention, 2 Months after the intervention
Method of measurement
scale, Kg/m²

Intervention groups

1

Description
Pearl vitamin D3, 50000 unit, Manufacturing of Razi Pharmaceutical Company, each week one for 10 week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Endocrinology Clinic
Full name of responsible person
Zahra Alian
Street address
pediatric ward 2, Besat Hospital, Shahid Motahari Blvd.
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Doctor Heidar Tavilani
Street address
Vice chancellor for research, School of Medicine, Shahid Fahmide Street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Medicine, Sciences Hamedan University of Medical
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric ward 2, Besat hospital, Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 1264 0063
Fax
Email
z_alian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine, Sciences Hamedan University of Medical
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric ward 2, Besat hospital, Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 1264 0063
Fax
+98 81 1264 0064
Email
z_alian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine, Sciences Hamedan University of Medical
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric ward 2, Besat hospital, Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 1264 0063
Fax
Email
z_alian@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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