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

NCT ID: NCT01894295

Last Updated: 2013-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Vitamin D analogue

1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.

Group Type EXPERIMENTAL

Vitamin D analogue

Intervention Type DIETARY_SUPPLEMENT

1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks

Placebo

Corn oil pearl Capsules 1 gram

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks

Interventions

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Placebo

Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Vitamin D analogue

1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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corn oil capsule 1-α hydroxyvitamin D3

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Jalali, PhD

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Khadijeh Mirzaei, MS

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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TehranUMS

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mahmoud Jalali, Phd

Role: CONTACT

+982188954911

Khadijeh Mirzaei, MS

Role: CONTACT

+989124379670

Facility Contacts

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Mahmoud Jalali, PhD

Role: primary

Khadijeh Mirzaei, MS

Role: backup

Other Identifiers

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91-03-27-18831

Identifier Type: -

Identifier Source: org_study_id

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