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Zinc Supplementation and Behçet's Syndrome

NCT ID: NCT05098678

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-22

Study Completion Date

2021-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Behcet Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zinc gluconate

zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc)

Group Type EXPERIMENTAL

Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

120 mg each tablet containing 30 mg elemental zinc

Control

Placebo (microcrystalline cellulose): 1 tablet (120 mg each)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (microcrystalline cellulose): 1 tablet (120 mg each)

Interventions

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Zinc gluconate

120 mg each tablet containing 30 mg elemental zinc

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (microcrystalline cellulose): 1 tablet (120 mg each)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabriz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Beitullah Alipour

Beitullah Alipour, Ph.D., Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 35413570 (View on PubMed)

Other Identifiers

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64693

Identifier Type: -

Identifier Source: org_study_id