NCT05098678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 15, 2021

Last Update Submit

October 27, 2021

Conditions

Behcet Syndrome

Outcome Measures

Primary Outcomes (9)

  • Toll-like Receptor-2 gene expression

    2-ΔΔCT

    12 weeks

  • Toll-like Receptor-4 gene expression

    2-ΔΔCT

    12 weeks

  • Toll-like Receptor-2 protein expression

    The mean fluorescence intensity

    12 weeks

  • Toll-like Receptor-4 protein expression

    The mean fluorescence intensity

    12 weeks

  • Serum level of tumor necrosis factor-alpha

    pg/ml

    12 weeks

  • NLRP3 gene expression

    2-ΔΔCT

    12 weeks

  • Caspase-1 gene expression

    2-ΔΔCT

    12 weeks

  • Serum level of interleukin-1 beta

    pg/ml

    12 weeks

  • Serum level of zinc

    ug/dl

    12 weeks

Secondary Outcomes (2)

  • Behçet's disease quality-of-life

    12 weeks

  • Disease activity

    12 weeks

Study Arms (2)

Zinc gluconate

EXPERIMENTAL

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

Dietary Supplement: Zinc gluconate

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Zinc gluconateDIETARY_SUPPLEMENT

120 mg each tablet containing 30 mg elemental zinc

Zinc gluconate
PlaceboDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, 5166614756, Iran

Location

Related Publications (1)

  • 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.

    PMID: 35413570DERIVED

MeSH Terms

Conditions

Behcet Syndrome

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Beitullah Alipour, Ph.D., Prof.

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 28, 2021

Study Start

August 22, 2020

Primary Completion

May 22, 2021

Study Completion

September 22, 2021

Last Updated

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)