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Zinc Supplementation and Behçet's Syndrome

Primary Purpose

Behcet Syndrome

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Zinc gluconate
Placebo
Sponsored by
Tabriz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet Syndrome

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tabriz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc gluconate

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Toll-like Receptor-2 gene expression
2-ΔΔCT
Toll-like Receptor-4 gene expression
2-ΔΔCT
Toll-like Receptor-2 protein expression
The mean fluorescence intensity
Toll-like Receptor-4 protein expression
The mean fluorescence intensity
Serum level of tumor necrosis factor-alpha
pg/ml
NLRP3 gene expression
2-ΔΔCT
Caspase-1 gene expression
2-ΔΔCT
Serum level of interleukin-1 beta
pg/ml
Serum level of zinc
ug/dl

Secondary Outcome Measures

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.
Disease activity
Behcets Disease Activity

Full Information

First Posted
October 15, 2021
Last Updated
October 27, 2021
Sponsor
Tabriz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05098678
Brief Title
Zinc Supplementation and Behçet's Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2020 (Actual)
Primary Completion Date
May 22, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tabriz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc gluconate
Arm Type
Experimental
Arm Description
zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc gluconate
Intervention Description
120 mg each tablet containing 30 mg elemental zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
Primary Outcome Measure Information:
Title
Toll-like Receptor-2 gene expression
Description
2-ΔΔCT
Time Frame
12 weeks
Title
Toll-like Receptor-4 gene expression
Description
2-ΔΔCT
Time Frame
12 weeks
Title
Toll-like Receptor-2 protein expression
Description
The mean fluorescence intensity
Time Frame
12 weeks
Title
Toll-like Receptor-4 protein expression
Description
The mean fluorescence intensity
Time Frame
12 weeks
Title
Serum level of tumor necrosis factor-alpha
Description
pg/ml
Time Frame
12 weeks
Title
NLRP3 gene expression
Description
2-ΔΔCT
Time Frame
12 weeks
Title
Caspase-1 gene expression
Description
2-ΔΔCT
Time Frame
12 weeks
Title
Serum level of interleukin-1 beta
Description
pg/ml
Time Frame
12 weeks
Title
Serum level of zinc
Description
ug/dl
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Behçet's disease quality-of-life
Description
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.
Time Frame
12 weeks
Title
Disease activity
Description
Behcets Disease Activity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tabriz University of Medical Sciences
City
Tabriz
State/Province
East Azerbaijan
ZIP/Postal Code
5166614756
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35413570
Citation
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.
Results Reference
derived

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Zinc Supplementation and Behçet's Syndrome

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