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

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Vitamin D analogue; Dietary Supplement: Placebo

• Registration Number: NCT01894295
• Lead Sponsor: Tehran University of Medical Sciences

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 available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D analogue	Vitamin D analogue	1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.
Placebo	Placebo	Corn oil pearl Capsules 1 gram

Primary Outcome Measures

Name	Time	Method
Resting Metabolic Rate	Change from baseline to 8 weeks	Measurement by indirect calorimetry.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

TehranUMS; 🇮🇷 Tehran, Iran, Islamic Republic of