Back to resultsAssessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Placebo
Vitamin D analogue
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Vitamin D analogues, Resting Metabolic rate, obesity
Eligibility Criteria
Inclusion Criteria:
Age 22-52 years Body mass index equal or more than 30
Exclusion Criteria:
Acute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug
Sites / Locations
- TehranUMSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D analogue
Placebo
Arm Description
1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.
Corn oil pearl Capsules 1 gram
Outcomes
Primary Outcome Measures
Resting Metabolic Rate
Measurement by indirect calorimetry.
Secondary Outcome Measures
Changes of Nesfatin-1, PPARγ and PGC1α protein levels
Measurement by ELISA kit
Full Information
NCT ID
NCT01894295
First Posted
July 3, 2013
Last Updated
July 9, 2013
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01894295
Brief Title
Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the resting metabolic rate. Moreover, the investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α) protein which may lead to change in metabic rate following treatment with either alphacalcidol or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Vitamin D analogues, Resting Metabolic rate, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D analogue
Arm Type
Experimental
Arm Description
1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Corn oil pearl Capsules 1 gram
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
corn oil capsule
Intervention Description
Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D analogue
Other Intervention Name(s)
1-α hydroxyvitamin D3
Intervention Description
1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks
Primary Outcome Measure Information:
Title
Resting Metabolic Rate
Description
Measurement by indirect calorimetry.
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Changes of Nesfatin-1, PPARγ and PGC1α protein levels
Description
Measurement by ELISA kit
Time Frame
Change from baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Change of ACS and FASN Enzymes
Description
Measurement by ELISA kit
Time Frame
Change from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 22-52 years Body mass index equal or more than 30
Exclusion Criteria:
Acute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Jalali, Phd
Phone
+982188954911
Email
jalalimahmoud@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khadijeh Mirzaei, MS
Phone
+989124379670
Email
mina_mirzaei101@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Jalali, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khadijeh Mirzaei, MS
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
TehranUMS
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Jalali, PhD
Email
jalalimahmoud@hotmail.com
First Name & Middle Initial & Last Name & Degree
Khadijeh Mirzaei, MS
Email
mina_mirzaei101@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
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