ObesityNCT01894295
Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
A study testing Vitamin D analogue in people with Obesity, run by Tehran University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 22 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Vitamin D analogue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIran
- Study dates
- Jun 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 22-52 years Body mass index equal or more than 30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
TehranUMS
Tehran, Tehran Province
Mahmoud Jalali, PhD, jalalimahmoud@hotmail.com
Khadijeh Mirzaei, MS, mina_mirzaei101@yahoo.com
About this study
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.
- Conditions
- Obesity
- Being tested
- Placebo, Vitamin D analogue
- Keywords
- Vitamin D analogues, Resting Metabolic rate, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called corn oil capsule
Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks
Vitamin D analogueDietary supplement
Also called 1-α hydroxyvitamin D3
1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D analogue | Experimental | 1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram. Receives: Dietary Supplement: Vitamin D analogue |
| Placebo | Placebo comparator | Corn oil pearl Capsules 1 gram Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate
Measurement by indirect calorimetry.
Measured: Change from baseline to 8 weeks
Secondary outcomes (1)
Changes of Nesfatin-1, PPARγ and PGC1α protein levels
Measurement by ELISA kit
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Jalali, PhD, Study director, Tehran University of Medical SciencesKhadijeh Mirzaei, MS, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894295
- Sponsor's protocol ID
- 91-03-27-18831
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
- ClinicalTrials.gov ID
- NCT01894295
- Acronym / sponsor ID
- 91-03-27-18831
- Conditions
- Obesity
- Keywords
- Vitamin D analogues, Resting Metabolic rate, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D analogue | Experimental | Dietary Supplement: Vitamin D analogue1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCorn oil pearl Capsules 1 gram |
Who may qualify
- Ages
- 22 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 22-52 years Body mass index equal or more than 30
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: corn oil capsuleCorn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks | Dietary supplement | Placebo |
| Vitamin D analogueAlso: 1-α hydroxyvitamin D31-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks | Dietary supplement | Vitamin D analogue |
Primary outcome
Resting Metabolic Rate
Time frame: Change from baseline to 8 weeks
Measurement by indirect calorimetry.
1 secondary outcome
Changes of Nesfatin-1, PPARγ and PGC1α protein levels
Time frame: Change from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Jalali, PhD study director
Tehran University of Medical Sciences
Khadijeh Mirzaei, MS principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D analogue in people with Obesity, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Jalali, Phd (+982188954911, jalalimahmoud@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Metabolic Rate (time frame: Change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.