The study is conducted as a clinical trial on the obese and overweight children and adolescents with vitamin D deficiency or insufficiency patients are between the ages of 2 and 18year. Inclusion criteria: children 2- 18 year, Exclusion criteria :recent use of vitamin D preparations(for last six months); the disorders of the calcium ,phosphorus and vitamin D metabolism; the use of medication affecting vitamin D metabolism such as antiepileptics and estrogens ;malabsorbtion disorders such as celiac disease, cystic fibrosis, etc.; endocrine disorders such as cushing's disease, hypothyroidism, pseudohypoparathyroidism, etc; any acute or chronic illness; or the use of alcohol or tobacco. The subjects will divided upon BMI: 1) Obese: BMI at or above the 95th percentile for age and gender, 2) Overweight: BMI at or above the 85th percentile and lower than 95th percentile for age and gender, 3) Normal weight: BMI lower than 85th percentile for age and gender. Serum level of 25OHD level will measured. Vitamin D deficiency was defined as a 25OHD level of <15 ng/ml and vitamin D insufficiency as a 25OHD level of 15–20 ng/ml(26, 27).Vitamin D sufficiency considered as 25OHD level of ≥20 ng/mL(26). Subjects with vitamin D deficiency or insufficiency will treat with one pearl of vitamin D (50,000 IU) once a week for 6 weeks. Vitamin D3 pearls were provided by Alhavi Company Iran. A second blood sample for the measurement of 25OHD level will obtain 2-6 months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090812421N2
Registration date:2014-10-01, 1393/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-01, 1393/07/09
Registrant information
Name
Kobra Shiasi arani
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5557 4430
Email address
shiasi_k@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An oral vitamin D regimen for hypovitaminosis D in obese children and adolescents
Public title
An oral vitamin D regimen for hypovitaminosis D in obese children and adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:children 2- 18 year
Exclusion criteria :recent use of vitamin D preparations(for last six months); the disorders of the calcium ,phosphorus and vitamin D metabolism;the use of medication affecting vitamin D metabolism such as antiepileptics and estrogens;malabsorbtion disorders such as celiac disease, cystic fibrosis, etc.;endocrine disorders such as cushing's disease, hypothyroidism, pseudohypoparathyroidism, etc; any acute or chronic illness; or the use of alcohol or tobacco.
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
ethical committees of Kashan University of Medical Sciences
Street address
Kashan university of medical sciences
City
kashan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
ب/29/5/1/1506
Health conditions studied
1
Description of health condition studied
vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
serum vitamin D level>= 20 ng/ml
Timepoint
0, 2 ,4 month
Method of measurement
the chemiluminescence assay
Secondary outcomes
empty
Intervention groups
1
Description
one pearl of vitamin D (50,000 IU) once a week for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
pediatric endocrinology clinic of Kashan University of Medical Sciences
Full name of responsible person
Kobra Shiasi Arani
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidi
Street address
Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Kobra Shiasi Arani
Position
Pediatric Endocrinologist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 31 5557 4430
Fax
Email
kobra.shiasi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kobra Shiasi Arani
Position
Pediatric Endocrinologist
Other areas of specialty/work
Street address
Shahid beheshti hospital, Kashan
City
Kashan
Postal code
Phone
+98 31 5557 4430
Fax
Email
shiasi_k@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kobra Shiasi Arani
Position
Other areas of specialty/work
Street address
Shahid beheshti hospital, Kashan
City
Kashan
Postal code
Phone
+98 31 5557 4430
Fax
Email
kobra.shiasi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)