Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303690944300 Date of Approval: 20/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impacts of Zinc enriched Spirulina supplementation on antioxidant capacity, pulmonary function, endothelial damage and social disadvantage data of Chronic Obstructive Pulmonary Disease patients: a Tunisian pilot study
Official scientific title Impacts of Zinc enriched Spirulina supplementation on antioxidant capacity, pulmonary function, endothelial damage and social disadvantage data of Chronic Obstructive Pulmonary Disease patients: a Tunisian pilot study
Brief summary describing the background and objectives of the trial Obstructive Pulmonary Disease (COPD) is a respiratory condition of increasing interest, with progressive and irreversible airflow limitation. COPD is strongly related to oxidative stress. Currently, antioxidants are naturally acquired through herbs, so that their antioxidant properties are extensively evaluated. There is a need for a different system to guide COPD pharmacological management during follow-up. Therefore, clinicians are actively seeking safer treatments. Given the high costs of COPD Treatment Strategies, antioxidant therapy has been developed as a preventive approach. Indeed, the use of medicinal plant extracts for the patients’ treatment has been largely noticed. While relatively limited clinical studies have been performed in humans, spirulina offers a significant antioxidant activity that makes it a potential treatment for COPD. Treatment with spirulina, a type of blue-green Algae, is one of the pillars of the phytotherapy, and it is advantageous in the treatment of several conditions and has achieved significant effects. Therefore, a simple, easy, safe, and effective trial is needed. Based on these effects, we intend to further studies on the effect of spirulina on COPD. Hence, spirulina consumption may exert beneficial effects on enhancement of antioxidant system. Therefore, the beneficial health effects of this algae should be confirmed by new randomized and rigorous clinical trials. Thus, the present study will be carried out to investigate the effects of spirulina in COPD patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SPIRICOPD
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/01/2023
Actual trial start date 15/01/2023
Anticipated date of last follow up 15/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group zinc enriched spirulina supplementation 1 g per day of spirulina + basic treatment 2 months A group (group G1) including adult male COPD aged 20 to 65 years. This group will receive zinc-enriched spirulina in conjunction with their basic treatment. 45
Control Group Control group to the G1 0 g of spirulina + basic tratment 2 months This group will serve as a control for the G1 group 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Two groups will be included in this study. The following inclusion criteria will be applied: - A first group (Group G1) will be formed by COPD male subjects aged 20 to 65 years. The COPD obstruction must be classified mild, moderate or severe according to GOLD guidelines respectively - A second group (Group G2) will be formed by COPD male adults aged 20-65 years. the postbronchodilator FEV1 must be higher than 30% of predicted value. This group will serve as a control for the G1. - contra-indications to 6MWT (signs of unstable angina or myocardial infarction within the previous month, resting heart rate ≥ 120 bpm, systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 100 mmHg) - Patients with limited physical activity and who cannot perform 6MWT (A known neuromuscular, orthopedic, rheumatologic or vascular disorders affecting the ability to exercise) - Patient who has been in further clinical trials in the previous year. - contra-indications to plethysmography. - deterioration of clinical status requiring hospitalization 3 months before the study - Asthmatic disease, Asthma-COPD Overlap - An upper airway abnormality. - History of chronic diseases (cardiac, renal, gastrointestinal, neurological; otorhinolaryngologic). - Acute upper respiratory tract infection during the three weeks preceding the evaluation - Acute exacerbation of COPD in the last 4 weeks. - Clinical manifestations of allergic diseases (urticaria, skin allergy, atopic dermatitis, eczema) - Inability to perform respiratory maneuvers properly Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 65 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/10/2022 ETHICS COMMITTEE FMSO
Ethics Committee Address
Street address City Postal code Country
Mohamed Karoui street Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the determination of antioxidant status (SOD, GPX, TAC, Homocysteine, uric acid) the begenning of the study: day 0, 2 months later, 3 months later
Secondary Outcome Symptom scores (mMRC) Social disadvantage (CAT, HAD) Exercise tolerance (6MWT, Voorrips questionnaire) Lung function (FEV1, FEV1/FVC, FEV1%, TLC, FRC, RV, TLCO) Endothelial function Inflammatory indicators (CRP, IL6) HbA1c the begenning of the study: day 0, 1 month later, 2 months later, 3 months later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Laboratory of physiology and functional explorations Farhat Hached Hospital Avenue Ibn El Jzzar Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Laboratory LR12SP09 Ibn El Jazzar Sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Laboratory bio algues El Alia BP51 Ksour Essef Mahdia 5180 Tunisia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amani SAYHI amanisayhi2007@gmail.com +21621517194 Jawhara
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia University of Sousse
Role Name Email Phone Street address
Principal Investigator Balsam Barkous balsam.barkous@gmail.com +21697336654 Jawhara
City Postal code Country Position/Affiliation
Sousse 4054 Tunisia University of Sousse
Role Name Email Phone Street address
Scientific Enquiries Sonia Rouatbi sonia.rouatbi@gmail.com +21697644064 Khzema
City Postal code Country Position/Affiliation
Sousse Tunisia University of Sousse
Role Name Email Phone Street address
Public Enquiries Khawla Mahmoudi khawlamahmoudi30@gmail.com +21655939314 Jawhara
City Postal code Country Position/Affiliation
Sousse Tunisia University of Sousse
Role Name Email Phone Street address
Scientific Enquiries Imed Latiri ilatiri@gmail.com +21652195346 Hammem Sousse
City Postal code Country Position/Affiliation
Sousse Tunisia University of Sousse
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data will be shared in an anonymous way Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 03 years Controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information