Generalized EpilepticNCT01764516
Study on Serum Zinc and Selenium Levels in Epileptic Patients
An observational study of Generalized Epileptic, run by Arak University of Medical Sciences at 1 site in Iran.
Trial summary
This study was carried out with the purpose of evaluating zinc and selenium levels in serum of epileptic patients and compare with normal individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Epileptic
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Nov 2011to May 2012
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: all generalized and single epileptic patiants which were identify for fist time
Who may be able to join
- New generalized and single epileptic cases patients who accept and sign the approval form of ethical committee non smoker, no trauma, no use of selenium supplement, no use of zinc supplement, no use of vitamin A supplement, no use of vitamin D supplement, no Weight loss, no Diarrhea, no addiction, no alcohol consumption, no use of certain medications,
Who cannot join
- presence of above criteria as well as, generalized and single epileptic cases under treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arak University of Medical Sciences , Ministry of Health and Education,I.R.Iran
This study was carried out with the purpose of evaluating zinc and selenium levels in serum of epileptic patients and compare with normal individuals.
Read the detailed description
Forty patients aged 18 to 50 years visiting Vali-Asr hospital in Arak, I.R. Iran, who were diagnosed with generalized form of epilepsy by a neurologist for the first time were recruited as cases. The control group (n=40) was selected from healthy individuals, in whom no disease was diagnosed until this study, and were matched to the case group by age, sex, and economical status.
- Conditions
- Generalized Epileptic
- Keywords
- zinc, selenium, serum, epilepsy, antioxidants
- Medical subject headings
- Epilepsy, Generalized, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Zinc level (micro gram per deciliter) | In all cases | |
| Selenium level (micro gram per deciliter) | In all cases | |
| Zinc level in male (micro gram per deciliter) | Not described | |
| Selenium level in male (micro gram per deciliter) | Not described | |
| Zinc level in Female (micro gram per decilitre) | Not described | |
| Selenium level in Female (micro gram per decilitre) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study on Serum Zinc and Selenium Levels in Epileptic Patients
decrement in serum zinc and selenium level
Measured: 5 months
Secondary outcomes (1)
Comparison between the selenium levels by gender in two groups
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized EpilepticStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Arak University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Farahani Heidar, Arak University of Medical Sciences
- Investigators
- Heidar N Farahani, PhD, Principal investigator, Department of Biochemistry,Arak medical sciences university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764516
- Sponsor's protocol ID
- f110@1958
- Other IDs
- f110@19588, f110@19588, f110@19588
- Status last verified
- Jan 2013
- First submitted
- 5 Jan 2013
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arak University of Medical Sciences , Ministry of Health and Education,I.R.Iran
- ClinicalTrials.gov ID
- NCT01764516
- Acronym / sponsor ID
- f110@1958
- Conditions
- Generalized Epileptic
- Keywords
- zinc, selenium, serum, epilepsy, antioxidants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Arak University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Jan 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.
This study was carried out with the purpose of evaluating zinc and selenium levels in serum of epileptic patients and compare with normal individuals.
Detailed description
Forty patients aged 18 to 50 years visiting Vali-Asr hospital in Arak, I.R. Iran, who were diagnosed with generalized form of epilepsy by a neurologist for the first time were recruited as cases. The control group (n=40) was selected from healthy individuals, in whom no disease was diagnosed until this study, and were matched to the case group by age, sex, and economical status.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Zinc level (micro gram per deciliter) | – | –In all cases |
| Selenium level (micro gram per deciliter) | – | –In all cases |
| Zinc level in male (micro gram per deciliter) | – | – |
| Selenium level in male (micro gram per deciliter) | – | – |
| Zinc level in Female (micro gram per decilitre) | – | – |
| Selenium level in Female (micro gram per decilitre) | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all generalized and single epileptic patiants which were identify for fist time
Key inclusion criteria (1 listed)
- New generalized and single epileptic cases patients who accept and sign the approval form of ethical committee non smoker, no trauma, no use of selenium supplement, no use of zinc supplement, no use of vitamin A supplement, no use of vitamin D supplement, no Weight loss, no Diarrhea, no addiction, no alcohol consumption, no use of certain medications,
Key exclusion criteria (1 listed)
- presence of above criteria as well as, generalized and single epileptic cases under treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study on Serum Zinc and Selenium Levels in Epileptic Patients
Time frame: 5 months
decrement in serum zinc and selenium level
1 secondary outcome
Comparison between the selenium levels by gender in two groups
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Heidar N Farahani, PhD principal investigator
Department of Biochemistry,Arak medical sciences university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Epileptic, run by Arak 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: finished, as of the sponsor's last update on 9 Jan 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study on Serum Zinc and Selenium Levels in Epileptic Patients (time frame: 5 months). 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 9 Jan 2013.