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Assessing the Effects of Alfacalcidol Intake on Expression of Involed Gene in Metabolism in Obese Subjects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Tehran University of Medical Sciences Identifier:
First received: December 14, 2012
Last updated: December 24, 2012
Last verified: December 2012
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.

Condition Intervention
Dietary Supplement: Placebo
Dietary Supplement: Alfacalcidol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Assessing the Effects of Supplementary Alfacalcidol Intake on Peroxisome Proliferator-activated Receptor-coactivator-1α, Vitamin D Receptor and Peroxisome Proliferator-activated Receptor Gamma Gene Expression in Obese Subjects

Resource links provided by NLM:

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Expression of VDR, PPARγ and PGC1α gene [ Time Frame: Change from baseline to 8 weeks ]
    measurement of Relative gene expression with RT-PCR.

Secondary Outcome Measures:
  • Change of weight [ Time Frame: Change from baseline to 8 weeks ]
    measurement with Body composition device

Other Outcome Measures:
  • Body mass index change [ Time Frame: Change from baseline to 8 weeks ]
    calculated with BMI equation

Estimated Enrollment: 94
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alfacalcidol
Dietary Supplement: Alfacalcidol
Other Names:
  • One-Alpha® Capsules 1 microgram
  • 1-α hydroxyvitamin D3
Placebo Comparator: Placebo
Corn oil pearl Capsules 1 gram: were given to the intervention group once a day for 8 weeks
Dietary Supplement: Placebo
corn oil Capsules 1 gram: were given to the placebo group once a day for 8 weeks
Other Names:
  • corn oil capsule
  • Corn oil Pearl

Detailed Description:

Increasing evidence from human population studies and animal research has established correlative as well as causative links between chronic inflammation and insulin resistance. The anti-inflammatory characteristics of vitamin D have been demonstrated in previous studies. In addition to its role in bone and calcium metabolism, vitamin D is demonstrated to be influential in the regulation of different immune system functions and glucose homeostasis pathways. Although low levels of vitamin D have shown to be in close correlation with obesity, whether vitamin D deficiency is the cause or the consequence of obesity remains unclear. It is noteworthy that several studies have demonstrated that vitamin D deficiency is associated with an increased resistance to insulin.

The biologic effects of vitamin D are primarily mediated via the nuclear transcription factor, vitamin D receptor (VDR), which triggers the expression of vitamin D responsive genes. VDR is expressed on different immune cells such as monocytes, T-lymphocytes, and granulocytes. It is documented that VDR and PGC-1α show an overlapping pattern of expression. Furthermore, as the expression of PGC-1α and PPARγ are regulated via environmental stimuli such as diet, it could be suggested that the function of VDR function can also be altered in response to external stimuli. PGC-1α was demonstrated to be of a particular importance in amelioration of increased insulin sensitivity.

Accordingly, to evaluate whether alphacalcidol treatment in obese subjects who generally suffer from a low state chronic inflammation could affect the insulin resistance, we designed the current double blind clinical trial study to compare the effect of alfacalcidol with placebo on serum glucose, 25-OH vitamin D, PTH, and lipid profile levels as well as Homeostatic model assessment (HOMA) and quantitative insulin sensitivity check index (QUICKI) indexes as a markers of insulin resistance. Furthermore, to assess the possible cross talk between VDR and PPARγ, the gene expressions of these VDR, PPARγ and PGC1α were evaluated following a course of treatment with either alphacalcidol or placebo.


Ages Eligible for Study:   22 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 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

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Please refer to this study by its identifier: NCT01752244

Contact: Arash Hossein-nezhad, MD, PHD
Contact: Khadijeh Mirzaei, MS

Iran, Islamic Republic of
TehranUMS Recruiting
Tehran, Iran, Islamic Republic of
Contact: Arash Hossein-nezhad, MD, PhD   
Contact: Khadijeh Mirzaei, MS   
Principal Investigator: Arash Hossein-nezhad, MD, PhD         
Sub-Investigator: Khadijeh Mirzaei, Ms         
Sponsors and Collaborators
Tehran University of Medical Sciences
Principal Investigator: Arash Hossein-nezhad, MD, PhD Tehran University of Medical Sciences
Principal Investigator: Khadijeh Mirzaei, Ms Tehran University of Medical Sciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences Identifier: NCT01752244     History of Changes
Other Study ID Numbers: 91-02-27-18041
Study First Received: December 14, 2012
Last Updated: December 24, 2012

Keywords provided by Tehran University of Medical Sciences:
Obesity, vitamin D analogue, VDR, PPARg, PGC1a

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017