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The effects of Spirulina Platensis on anemia status in patients with ulcerative colitis

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History
# Registration date Revision Id
2 2021-04-01, 1400/01/12 176887
1 2020-05-14, 1399/02/25 134211
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  • General information

    empty
    In the exclusion criteria section, the use of anemia drugs has been added.
    empty
    در بخش معیارهای خروج، مصرف داروهای کم خونی اضافه شده است.
    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.
    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
    بیماران مبتلا به کولیت اولسروز شدید
    افراد باردار و شیرده
    دریافت داروهای ضد افسردگی و ضد اضطراب
    دریافت مکمل های انتی اکسیدانی و امگا 3 در سه ماه گذشته
    مصرف سیگار و الکل
    ابتلا به بیماری های کلیه ، کبد ، تیروئید و پاراتیروئید ، دستگاه گوارش و قلب و بیماری سرطان
    بیماران مبتلا به کولیت اولسروز شدید
    افراد باردار و شیرده
    دریافت داروهای ضد افسردگی و ضد اضطراب
    دریافت مکمل های انتی اکسیدانی و امگا 3 در سه ماه گذشته
    مصرف سیگار و الکل
    ابتلا به بیماری های کلیه ، کبد ، تیروئید و پاراتیروئید ، دستگاه گوارش و قلب و بیماری سرطان
    مصرف داروهای کم خونی

  • Primary outcomes

    #1
    Anemia status
    Red Blood Cell Count
    کم خونی
    شمارش سلول های قرمز خون
    Diagnostic kit
    Hematology Analysis
    کیت تشخیصی
    انالیز خون شناسی
    #2
    empty
    White blood cell
    empty
    گلبول سفید خون
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Hematology Analysis
    empty
    انالیز خون شناسی
    #3
    empty
    Hemoglobin
    empty
    هموگلوبین
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Hematology Analysis
    empty
    انالیز خون شناسی
    #4
    empty
    Mean corpuscular volume
    empty
    میانگین حجم هر گلبول
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Hematology Analysis
    empty
    انالیز خون شناسی
    #5
    empty
    Mean corpuscular hemoglobin
    empty
    متوسط هموگلوبین گلبول
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Hematology Analysis
    empty
    انالیز خون شناسی
    #6
    empty
    Mean corpuscular hemoglobin concentration
    empty
    متوسط غلظت هموگلوبین گلبول
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Hematology Analysis
    empty
    انالیز خون شناسی
    #7
    empty
    Ferritin
    empty
    فریتین
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Diagnostic kit
    empty
    کیت تشخیصی
    #8
    empty
    Serum Iron
    empty
    آهن سرم
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Diagnostic kit
    empty
    کیت تشخیصی
    #9
    empty
    Hematocrit
    empty
    هماتوکریت
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Hematology Analysis
    empty
    انالیز خون شناسی

  • Secondary outcomes

    #1
    empty
    Fecal occult blood
    empty
    خون مخفی در مدفوع
    empty
    Before intervention and 8 weeks after initiation of Spirulina supplementation
    empty
    قبل از مداخله و 8 هفته بعد از شروع مکمل یاری اسپیرولینا
    empty
    Diagnostic kit
    empty
    کیت تشخیصی

Protocol summary

Study aim
The aim of the study is evaluating the effects of spirulina supplementation on anemia status in patients with ulcerative colitis
Design
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.
Settings and conduct
This study will be done in clinic.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
anemia status

General information

Reason for update
In the exclusion criteria section, the use of anemia drugs has been added.
Acronym
IRCT registration information
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
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Fateme Parvizi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 9220
Email address
fatemeparvizi4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-04, 1398/10/14
Expected recruitment end date
2021-01-03, 1399/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Spirulina Platensis on anemia status in patients with ulcerative colitis
Public title
Spirulina Platensis in patients with ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Daneshgah Ave., Shahid Shiroodi Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
KUMS.REC.1398.1141

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.9
ICD-10 code description
Ulcerative colitis, unspecified

Primary outcomes

1

Description
Red Blood Cell Count
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

2

Description
White blood cell
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

3

Description
Hemoglobin
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

4

Description
Mean corpuscular volume
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

5

Description
Mean corpuscular hemoglobin
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

6

Description
Mean corpuscular hemoglobin concentration
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

7

Description
Ferritin
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Diagnostic kit

8

Description
Serum Iron
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Diagnostic kit

9

Description
Hematocrit
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Hematology Analysis

Secondary outcomes

1

Description
Fecal occult blood
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Diagnostic kit

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Mehdi Zubiri's office
Full name of responsible person
Mehdi Zobeiri
Street address
Ejlalieh building
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3728 4242
Email
mehdizobeiri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mehdi Zobeiri
Street address
Kermanshah University of Medical Sciences, Daneshgah Ave., Shahid Shiroodi Blv., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3728 4242
Email
mehdizobeiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Parvizi
Position
Investigator of Kermanshah University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Others
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 38 3429 9220
Fax
Email
parvizi_70@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehdi Zobeiri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3728 4242
Email
mehdizobeiri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehdi Zobeiri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastrointestinal
Street address
Kermanshah University of Medical Sciences, Daneshgah St., Sorkheligheh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3728 4242
Email
mehdizobeiri@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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