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Comparison of therapeutic response to identical oral Vitamin D between obese and non-obese children with vitamin D deficiency

Protocol summary

Summary
This study is a clinical trial to compare the prevalence of Vitamin D deficiency and therapeutic response to identical oral vitamin D therapy between obese and non-obese children. Inclusion criteria include: Ages between 2 to 14 years and Exclusion criteria include: Body Mass Index between 85 to 95 percentile for age, Ingestion of vitamin D, Multivitamin supplements usage, Anticonvulsants usage, Systemic corticosteroids usage, and chronic diseases. Study participants are children 2 to 14 years age, referring to endocrine clinic, vaccination clinic and general clinic. The sample size is 90 (45 in each group). After blood sampling, children with serum 25 hydroxy Vitamin D less than 30 Nano gram per milliliter of both groups, will be treated by 300,000 IU oral Vitamin D in 6 weeks (50,000 IU as a pearl, once a week).2-6 weeks after the treatment, Serum 25 hydroxy Vitamin D will be measured again. Assessment of differentiation in response to therapy between obese and non-obese groups is due to comparing their means of Vitamin D status before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012100210988N1
Registration date: 2012-11-14, 1391/08/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-11-14, 1391/08/24
Registrant information
Name
Fatemeh Sayarifard
Name of organization / entity
Tehran University of Medical Sciences,children medical center
Country
Iran (Islamic Republic of)
Phone
00982166935848-00982161475
Email address
f-sayarifard@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic response to identical oral Vitamin D between obese and non-obese children with vitamin D deficiency
Public title
Efficacy of oral Vitamin D therapy in children with Vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Child ; Ages 2-14 years Exclusion criteria: Body Mass Index between 85-95 percentile for age ; Ingestion of vitamin D ; Multivitamin supplements usage ; Anticonvulsants usage ; Systemic corticosteroids usage ; Presence of hepatic disease ; Presence of renal disease ; Presence of Endocrine disorders ; Presence of malabsorptive disorders ; Presence of cancer
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
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
Tehran University of Medical Sciences
Street address
Central Orgaznization of Tehran University of Medical Sciences, Qods Ave, Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2012-09-25, 1391/07/04
Ethics committee reference number
18226.65719

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

2

Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Primary 25-Hydroxy Vitamin D
Timepoint
Befor treatment
Method of measurement
ng/dl-laboratory kit

2

Description
Secondary 25-Hydroxy Vitamin D
Timepoint
2-6 weeks after the end of treatment
Method of measurement
ng/dl-laboratory kit

Secondary outcomes

1

Description
Secondary serum calcium
Timepoint
2-6 weeks after end of treatment
Method of measurement
mg/dl-laboratory kit

2

Description
Primary urine calcium-creatinin ratio
Timepoint
before treatment
Method of measurement
laboratory kit

3

Description
Secondary urine calcium-creatinin ratio
Timepoint
2-6 weeks after end of treatment
Method of measurement
laboratory kit

4

Description
Primary serum PTH
Timepoint
before treatment
Method of measurement
Pg/dl-laboratory kit

5

Description
Secondary serum PTH
Timepoint
2-6 weeks after end of treatment
Method of measurement
Pg/dl-laboratory kit

6

Description
Primary serum calcium
Timepoint
before treatment
Method of measurement
mg/dl-laboratory kit

7

Description
Secondary serum phosphorus
Timepoint
2-6 weeks after end of treatment
Method of measurement
mg/dl-laboratory kit

8

Description
primary serum phosphorus
Timepoint
before treatment
Method of measurement
mg/dl-laboratory kit

9

Description
primary serum alkaline phosphatase
Timepoint
before treatment
Method of measurement
Unit/l-laboratory kit

10

Description
secondary serum alkaline phosphatase
Timepoint
2-6 weeks after end of treatment
Method of measurement
Unit/l-laboratory kit

Intervention groups

1

Description
300,000 IU oral Vitamin D in 6 weeks(50,000 IU once a week) in Obese children with Vitamin D deficiency
Category
Treatment - Drugs

2

Description
300,000 IU oral Vitamin D in 6 weeks(50,000 IU once a week) in Non obese children with Vitamin D deficiency
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Dr. Fatemeh Sayarifard
Street address
Gharib Ave, Keshavarz Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
ِDr. Akbar Fotouhi
Street address
Central Orgaznization of Tehran University of Medical Sciences, Qods Ave, Keshavarz Blvd
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences, Children Medical Center
Full name of responsible person
Dr. Fatemeh Sayarifard
Position
Pediatric Endocrinologist/Assistant Professor
Other areas of specialty/work
Street address
Gharib Ave, Keshavarz Blvd
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
+98 21 6693 0024
Email
f-sayarifard@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Children Medical Center
Full name of responsible person
Dr. Fatemeh Sayarifard
Position
Pediatric Endocrinologist/Assistant Professor
Other areas of specialty/work
Street address
Gharib Ave, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
f-sayarifard@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, Children Medical Center
Full name of responsible person
Dr. Fatemeh Sayarifard
Position
Pediatric Endocrinologist/Assistant Professor
Other areas of specialty/work
Street address
Gharib Ave, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
f-sayarifard@tums.ac.ir
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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