NCT01752244

Brief Summary

Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin resistance. Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin D. Although analogues of vitamin D3 have extensively been used in the treatment of various chronic inflammatory diseases, to our knowledge, no such research is conducted in regards with obesity. The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the insulin resistance. Moreover, we will evaluate the pathways of Vitamin D receptor (VDR), Peroxisome proliferator-activated receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α) gene expressions which may lead to insulin resistance following treatment with either alphacalcidol or placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

December 14, 2012

Last Update Submit

December 24, 2012

Conditions

Obesity

Keywords

Obesity, vitamin D analogue, VDR, PPARg, PGC1a

Outcome Measures

Primary Outcomes (1)

  • Expression of VDR, PPARγ and PGC1α gene

    measurement of Relative gene expression with RT-PCR.

    Change from baseline to 8 weeks

Secondary Outcomes (1)

  • Change of weight

    Change from baseline to 8 weeks

Other Outcomes (1)

  • Body mass index change

    Change from baseline to 8 weeks

Study Arms (2)

Alfacalcidol

EXPERIMENTAL

Alfacalcidol

Dietary Supplement: Alfacalcidol

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

corn oil Capsules 1 gram: were given to the placebo group once a day for 8 weeks

Also known as: corn oil capsule, Corn oil Pearl
Placebo
AlfacalcidolDIETARY_SUPPLEMENT

Alfacalcidol

Also known as: One-Alpha® Capsules 1 microgram, 1-α hydroxyvitamin D3
Alfacalcidol

Eligibility Criteria

Age22 Years - 52 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 22-52 years Body mass index equal or more than 30

You may not qualify if:

  • Acute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers such as known cardiovascular disease Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TehranUMS

Tehran, Iran

RECRUITING

Related Publications (1)

  • Mirzaei K, Hossein-Nezhad A, Keshavarz SA, Eshaghi SM, Koohdani F, Saboor-Yaraghi AA, Hosseini S, Tootee A, Djalali M. Insulin resistance via modification of PGC1alpha function identifying a possible preventive role of vitamin D analogues in chronic inflammatory state of obesity. A double blind clinical trial study. Minerva Med. 2014 Feb;105(1):63-78.

    PMID: 24572452DERIVED

MeSH Terms

Conditions

ObesityCarotid Intimal Medial Thickness 1

Interventions

Corn Oilalfacalcidol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Arash Hossein-nezhad, MD, PhD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Khadijeh Mirzaei, Ms

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Hossein-nezhad, MD, PHD

CONTACT

arashh@bu.edu

Khadijeh Mirzaei, MS

CONTACT

mirzaei_kh@razi.tums.ac.ir

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 19, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

December 27, 2012

Record last verified: 2012-12

Locations

IR(1)