Assessment Vitamin D Analogues Intake Pathways on the Pro... | NCT01894295

Studies
Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects

NCT01894295

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 10, 2013Estimated

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Placebo
Vitamin D analogue

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Sep 2013Estimated

First Submitted Date

Jul 3, 2013

First Submission Date that Met QC Criteria

Jul 9, 2013

First Posted Date

Jul 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2013

Last Update Posted Date

Jul 10, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D analogue	Experimental	1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.	Dietary Supplement: Vitamin D analogue
Placebo	Placebo Comparator	Corn oil pearl Capsules 1 gram	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting Metabolic Rate	Measurement by indirect calorimetry.	Change from baseline to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes of Nesfatin-1, PPARγ and PGC1α protein levels	Measurement by ELISA kit	Change from baseline to 8 weeks

Other Outcomes

Measure	Description	Time Frame
Change of ACS and FASN Enzymes	Measurement by ELISA kit	Change from baseline to 8 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

52 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Jalali, Phd	Contact	+982188954911		jalalimahmoud@hotmail.com
Khadijeh Mirzaei, MS	Contact	+989124379670		mina_mirzaei101@yahoo.com

Overall Officials

Name	Affiliation	Role
Mahmoud Jalali, PhD	Tehran University of Medical Sciences	Study Director
Khadijeh Mirzaei, MS	Tehran University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TehranUMS	Recruiting	Tehran	Tehran Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003314	Corn Oil

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided