zinc supplementation in patients with ulcerative colitis: effects on clinical symptoms, and inflammatory/anti-inflammatory cytokines affecting the immune system
1. Determining and comparing the severity of clinical symptoms between the two groups at the end of the study
2. Determining and comparing the quality of life between the two groups at the end of the study
3. Determination and comparison of inflammatory markers (IL-17, TNF-α, and IL-6 serum levels) between the two groups at the end of the study
4. Determination and comparison of anti-inflammatory markers (serum IL-10) between two groups at the end of the study
Clinical - Rasool Akram Hospital - After the definitive diagnosis of ulcerative colitis, the questionnaires will be completed by the participants, and the next day they will be sent to the lab for sampling and they will receive the supplement on the same day. - The interviewer, the doctor, and the patient will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Age 18 to 50 years
- Body mass index between 18.5 and 35
- Definitive diagnosis of ulcerative colitis according to the colonoscopy image and intestinal sample pathology
- Mild to moderate active form of the disease
- Absence of concomitant diseases such as malignant diseases and other inflammatory diseases
- No recurrence of the disease in the last 3 months
- No intestinal surgery
- Not taking supplements containing zinc and other supplements during the last 2 months
- Not having a special diet
- No use of infliximab, Sinora, high dose of corticosteroids (above 40 mg), NSAIDs
- Not pregnant and breastfeeding
Intervention groups
Intervention with zinc gluconate in the intervention group
Intervention with placebo in the control group
zinc supplementation in patients with ulcerative colitis: effects on clinical symptoms, and inflammatory/anti-inflammatory cytokines affecting the immune system
Public title
"zinc supplementation"; "Ulcerative colitis"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index between 18.5 and 35
ِDiagnosis of ulcerative colitis according to the patient's symptoms, tests and colonoscopy, and intestinal sample pathology
Mild to moderate active form of the disease according to the Mayo questionnaire
Absence of concomitant diseases
not taking supplements containing zinc during the last 2 months
No use of infliximab, Sinora, high dose of corticosteroids (above 40 mg), NSAIDs
Not pregnant or lactating
Not taking contraceptives
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the patients, people are randomly assigned to two groups receiving a zinc gluconate supplement and a placebo. For randomization, permuted block randomization with 4 blocks and 2 blocks (based on age and BMI) will be used. The randomization unit will be individual. In order to apply concealment in the randomization process, unique codes will be used on the complementary boxes, and the desired code will be generated by the software and will be done with the envelope-sealed method with a random sequence. As each person enters the study based on the generated sequence, the supplementary package in which the desired code is registered will be allocated to the person, and therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Also, the person evaluating the patient (interrogator) and the attending physician will not be aware of the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply concealment (double-blind) in the randomization process, unique codes will be used on the complementary boxes, and the desired code will be generated by the software and will be done with the sealed envelope method. As each person enters the study based on the generated sequence, the supplementary package in which the desired code is recorded will be allocated to the person, and therefore, before choosing the person, no one will be not aware of the type of treatment he will receive. Also, the person evaluating the patient and the attending physician will not be aware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-04-26, 1401/02/06
Ethics committee reference number
IR.IUMS.REC.1401.054
Health conditions studied
1
Description of health condition studied
ulcerative colitis disease
ICD-10 code
K51.9
ICD-10 code description
Ulcerative colitis, unspecified
Primary outcomes
1
Description
severity of clinical symptoms
Timepoint
At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo)
Method of measurement
Mayo questionnaire
Secondary outcomes
1
Description
Serum level of Interlukin-6
Timepoint
At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo)
Method of measurement
In serum sample using ELISA kit
2
Description
Serum level of Interlukin-17
Timepoint
At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo)
Method of measurement
In serum sample using ELISA kit
3
Description
Serum level of TNF-α
Timepoint
At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo)
Method of measurement
In serum sample using ELISA kit
4
Description
Quality of life
Timepoint
At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo)
Method of measurement
Inflammatory Bowel Disease Quality of Life Short Questionnaire (IBDQ-9)
5
Description
Serum level of Interlukin-10
Timepoint
At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo)
Method of measurement
In serum sample using ELISA kit
Intervention groups
1
Description
Intervention group: Patients take one daily zinc gluconate softgel from Dana Pharmaceutical Company with 40 mg of elemental zinc and capsule filler (glycerol, gelatin, and lecithin) along with their therapeutic medications, including Mesalazine and Azaram, for 60 days. Capsules are given to patients in two bottles containing 30 softgel in each of them. The first bottle will be delivered to the patient on the day of sampling and instructions will be given on how to use it.
Category
Treatment - Drugs
2
Description
Control group: Patients take one daily placebo from Dana Pharmaceutical Company without any drug Compounds including zinc and a capsule filled with glycerol, gelatin, and lecithin along with their therapeutic medications, including Mesalazine and Azaram, for 60 days. Capsules are given to patients in two bottles containing 30 softgel in each of them. The first bottle will be delivered to the patient on the day of sampling and instructions will be given on how to use it.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Mohsen Masoodi
Street address
Rasool Akram Hospital, Maziar Mansouri Street, Sattar Khan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
+98 21 86701
Email
masoodi47@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Masoodi
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?