Protocol summary
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Study aim
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The aim of the study is evaluating the effects of spirulina supplementation on anemia status in patients with ulcerative colitis
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial. The third person places the placebo and spirulina into identical and similar capsules and containers and encodes them randomly. A simple randomization method using random number table is used, and each client receives its own number. In this study 80 individuals will participate. The first group of patients will receive Spirulina 1 g daily and the second group will be age- and sex-matched colitis patients who will be selected as controls and receive placebo. All participants will receive two 500 mg capsules daily. Anemia tests are taken from patients before the intervention and at the end of 8 weeks. finally, the result will be studied using SPSS software.
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Settings and conduct
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This study will be done in clinic.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients included in the study had mild or moderate levels of ulcerative colitis and were between 18 and 65 years of age. Exclusion criteria: Patients with severe ulcerative colitis or other chronic diseases. People during pregnancy or lactation. Smokers or alcohol users. Taking antidepressants and anxiety medications. Taking antioxidant and omega-3 supplements in the last three months.
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Intervention groups
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People with mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old will be assigned to receive spirulina supplements (n=40) and placebo (n=40). The group of patients in intervention group will receive Spirulina (Arthrospira platensis) 1 g daily (receive two 500 mg capsules daily) for 8 weeks, and the group of patients in the control group will receive starch 1 g daily (receive two 500 mg capsules daily) for 8 weeks.
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Main outcome variables
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anemia status
General information
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Reason for update
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In the exclusion criteria section, the use of anemia drugs has been added.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170802035460N3
Registration date:
2020-05-14, 1399/02/25
Registration timing:
registered_while_recruiting
Last update:
2021-04-01, 1400/01/12
Update count:
1
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Registration date
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2020-05-14, 1399/02/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-04, 1398/10/14
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Expected recruitment end date
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2021-01-03, 1399/10/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of Spirulina Platensis on anemia status in patients with ulcerative colitis
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Public title
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Spirulina Platensis in patients with ulcerative colitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients included in the study had mild or moderate levels of ulcerative colitis and were between 18 and 65 years of age.
Exclusion criteria:
Patients with severe ulcerative colitis or other chronic diseases.
People during pregnancy or lactation
Taking antidepressants and anxiety medications
Taking antioxidant and omega-3 supplements in the last three months.
Smokers or alcohol consumers
Patients with kidney, liver, thyroid and parathyroid, gastrointestinal and heart disease and cancer disease.
Taking anemia medications
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, a simple randomization method using random number table is used. This method first uses a random number table, which is a set of numbers that have no pattern or order and which is completely generated. The researcher divides these numbers randomly between the intervention and placebo groups. With the presence of clients, the researcher begins to read the numbers in the specified order. Each client receives its own number and is randomly assigned to either the intervention or the placebo group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a double-blind study. Given that the researcher and patient should not be aware of the contents of the capsules, the third person places the placebo and spirulina into identical and similar capsules and containers and encodes them randomly. Spirulina and placebo are then presented to the researcher with a code to disclose to the patient.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-08, 1399/01/20
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Ethics committee reference number
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KUMS.REC.1398.1141
Health conditions studied
1
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Description of health condition studied
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Ulcerative colitis
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ICD-10 code
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K51.9
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ICD-10 code description
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Ulcerative colitis, unspecified
Primary outcomes
1
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Description
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Red Blood Cell Count
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
2
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Description
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White blood cell
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
3
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Description
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Hemoglobin
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
4
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Description
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Mean corpuscular volume
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
5
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Description
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Mean corpuscular hemoglobin
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
6
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Description
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Mean corpuscular hemoglobin concentration
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
7
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Description
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Ferritin
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Diagnostic kit
8
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Description
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Serum Iron
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Diagnostic kit
9
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Description
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Hematocrit
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Hematology Analysis
Secondary outcomes
1
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Description
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Fecal occult blood
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Diagnostic kit
Intervention groups
1
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Description
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Intervention group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive Spirulina (Arthrospira platensis) 1 g daily (receive two 500 mg capsules daily) for 8 weeks.
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Category
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Treatment - Other
2
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Description
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Control group:People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive starch 1 g daily (receive two 500 mg capsules daily) for 8 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available