Behcet SyndromeNCT05098678
Zinc Supplementation and Behçet's Syndrome
A study testing Zinc gluconate in people with Behcet Syndrome, run by Tabriz University of Medical Sciences at 1 site in Iran.
Trial summary
To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- Zinc gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 22 Aug 2020to 22 Sep 2021
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 20 to 50 years (premenopausal woman)
- Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet's Disease)
- Patients who want to participate in the study
Who cannot join
- Pregnancy and lactation
- History of diabetes and other chronic diseases
- Smoking and alcohol consumption over the past year
- History of other autoimmune diseases
- Consumption of nutritional and antioxidant supplements over two months prior to the study
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tabriz University of Medical Sciences
Tabriz, East Azerbaijan Province, 5166614756
About this study
Official title: The Effects of Zinc Gluconate Supplementation on Several Genes Expression, the Serum Level of Inflammatory Factors, Quality of Life, and Disease Activity in Patients With Behcet Syndrome: Double-blind Randomized Controlled Clinical Trial
To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their diet, medication, and physical activity during the study. At the first and the end of the intervention, genes and proteins expression, the serum level of inflammatory factors, quality of life, disease activity, anthropometric measures, physical activity and serum level of zinc will be assessed and compared between groups.
- Conditions
- Behcet Syndrome
- Being tested
- Zinc gluconate, Placebo
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc gluconateDietary supplement
120 mg each tablet containing 30 mg elemental zinc
PlaceboDietary supplement
Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
| Study group | Role | What they receive |
|---|---|---|
| Zinc gluconate | Experimental | zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) Receives: Dietary Supplement: Zinc gluconate |
| Control | Placebo comparator | Placebo (microcrystalline cellulose): 1 tablet (120 mg each) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toll-like Receptor-2 gene expression
2-ΔΔCT
Measured: 12 weeks
Toll-like Receptor-4 gene expression
2-ΔΔCT
Measured: 12 weeks
Toll-like Receptor-2 protein expression
The mean fluorescence intensity
Measured: 12 weeks
Toll-like Receptor-4 protein expression
The mean fluorescence intensity
Measured: 12 weeks
Serum level of tumor necrosis factor-alpha
pg/ml
Measured: 12 weeks
NLRP3 gene expression
2-ΔΔCT
Measured: 12 weeks
Caspase-1 gene expression
2-ΔΔCT
Measured: 12 weeks
Serum level of interleukin-1 beta
pg/ml
Measured: 12 weeks
Serum level of zinc
ug/dl
Measured: 12 weeks
Secondary outcomes (2)
Behçet's disease quality-of-life
Behçet's disease quality-of-life. The score ranged between 0-30. Zero means high quality of life and 30 means low quality of life.
Measured: 12 weeks
Disease activity
Behcets Disease Activity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start22 Aug 2020
- Primary completion22 May 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beitullah Alipour, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098678
- Sponsor's protocol ID
- 64693
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faghfouri AH, Khabbazi A, Baradaran B, Khajebishak Y, Baghbani E, Noorolyai S, Rahmani S, Seyyed Shoura SM, Alipour M, Alipour B. Immunomodulatory and clinical responses to zinc gluconate supplementation in patients with Behcet's disease: A double-blind, randomized placebo-controlled clinical trial. Clin Nutr. 2022 May;41(5):1083-1092. doi: 10.1016/j.clnu.2022.03.019. Epub 2022 Mar 30.
PubMed 35413570
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Zinc Gluconate Supplementation on Several Genes Expression, the Serum Level of Inflammatory Factors, Quality of Life, and Disease Activity in Patients With Behcet Syndrome: Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05098678
- Acronym / sponsor ID
- 64693
- Conditions
- Behcet Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Study start
- 22 Aug 2020 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 28 Oct 2021 (actual)
- 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.
To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their diet, medication, and physical activity during the study. At the first and the end of the intervention, genes and proteins expression, the serum level of inflammatory factors, quality of life, disease activity, anthropometric measures, physical activity and serum level of zinc will be assessed and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc gluconate | Experimental | Dietary Supplement: Zinc gluconatezinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) |
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo (microcrystalline cellulose): 1 tablet (120 mg each) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range 20 to 50 years (premenopausal woman)
- Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet's Disease)
- Patients who want to participate in the study
Key exclusion criteria (5 listed)
- Pregnancy and lactation
- History of diabetes and other chronic diseases
- Smoking and alcohol consumption over the past year
- History of other autoimmune diseases
- Consumption of nutritional and antioxidant supplements over two months prior to the study
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 |
|---|---|---|
| Zinc gluconate120 mg each tablet containing 30 mg elemental zinc | Dietary supplement | Zinc gluconate |
| PlaceboPlacebo (microcrystalline cellulose): 1 tablet (120 mg each) | Dietary supplement | Control |
Primary outcome
Toll-like Receptor-2 gene expression
Time frame: 12 weeks
2-ΔΔCT
Toll-like Receptor-4 gene expression
Time frame: 12 weeks
2-ΔΔCT
Toll-like Receptor-2 protein expression
Time frame: 12 weeks
The mean fluorescence intensity
Toll-like Receptor-4 protein expression
Time frame: 12 weeks
The mean fluorescence intensity
Serum level of tumor necrosis factor-alpha
Time frame: 12 weeks
pg/ml
NLRP3 gene expression
Time frame: 12 weeks
2-ΔΔCT
Caspase-1 gene expression
Time frame: 12 weeks
2-ΔΔCT
Serum level of interleukin-1 beta
Time frame: 12 weeks
pg/ml
Serum level of zinc
Time frame: 12 weeks
ug/dl
2 secondary outcomes
Behçet's disease quality-of-life
Time frame: 12 weeks
Disease activity
Time frame: 12 weeks
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 4 Nov 2021.
- Derived from this study: PubMed 35413570Faghfouri AH, Khabbazi A, Baradaran B, Khajebishak Y, Baghbani E, Noorolyai S, Rahmani S, Seyyed Shoura SM, Alipour M, Alipour B. Immunomodulatory and clinical responses to zinc gluconate supplementation in patients with Behcet's disease: A double-blind, randomized placebo-controlled clinical trial. Clin Nutr. 2022 May;41(5):1083-1092. doi: 10.1016/j.clnu.2022.03.019. Epub 2022 Mar 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc gluconate in people with Behcet Syndrome, run by Tabriz 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 3 inclusion and 5 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 4 Nov 2021. 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?
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?
Toll-like Receptor-2 gene expression (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098678, which also lists 1 linked publication.
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 4 Nov 2021.