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

Obesity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01894295
• Other study ID #: 91-03-27-18831
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2013
• Last updated: July 9, 2013
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2013
• Source: Tehran University of Medical Sciences
• Contact: Mahmoud Jalali, Phd
• Phone: +982188954911
• Email: jalalimahmoud[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 52 Years

Eligibility

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 PPAR? agonist drug

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Placebo
Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks
• Vitamin D analogue
1-a hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	TehranUMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of ACS and FASN Enzymes	Measurement by ELISA kit	Change from baseline to 8 weeks	No
Primary	Resting Metabolic Rate	Measurement by indirect calorimetry.	Change from baseline to 8 weeks	No
Secondary	Changes of Nesfatin-1, PPAR? and PGC1a protein levels	Measurement by ELISA kit	Change from baseline to 8 weeks	No