- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03535974
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules (ESSAY)
May 6, 2020 updated by: Fundatia Bio-Forum
Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules
Clinical trial with a double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo.
Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient.
It is expected that a decrease in the thyroid nodules occurs with the supplement administration.
Compared with placebo there will be a decrease of at least 20% in the volume or the largest diameter of the nodules during the 6-week administration of the supplement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Clinical trial with double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo.
- The sequence of administration supplement - placebo is unknown to the doctor or the patients
- The supplement and placebo are placed in identical capsules and vials by DVR Pharm
- The respective capsules are administered twice a day Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient.
- Echography and blood tests will be performed for each patient initially, after 6 weeks, and after 12 weeks It is expected that a decrease in the thyroid nodules occurs with the supplement administration.
- there will be a direct comparison of the nodules dimensions on the ecographic examinations, in millimeters, and of the blood levels of the molecules which reflect thyroid function
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bucuresti
-
Bucharest, Bucuresti, Romania, 040245
- Fundatia Bio-Forum
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- euthyroid adults (normal TSH)
- no criteria for malignancy is present (size, fine needle aspiration, lymph nodules)
- no other medication/supplement administered for thyroid, no steroids, beta-blocker
Exclusion Criteria:
- suspicion of malignancy / shown
- autoimmune disease
- abnormal thyroid function
- Wilson disease
- contraception with intrauterine device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Preparation with Spirulina
6 weeks bid Preparation with Spirulina
|
Preparation with Spirulina to ameliorate the size of benign thyroid nodules
|
Placebo Comparator: Placebo
6 weeks bid Placebo
|
Placebo administration for 6 weeks bid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Area of Thyroid Nodules
Time Frame: after 6 weeks of administration of the supplement and placebo
|
Size of the thyroid nodules is measured by ultrasound, two perpendicular diameters, same incidence and operator at V1 and V2 Area of nodules is calculated as the product of the two diameters
|
after 6 weeks of administration of the supplement and placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Corin Badiu, M.D., Institutul Parhon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2018
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
December 21, 2018
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
May 23, 2018
First Posted (Actual)
May 24, 2018
Study Record Updates
Last Update Posted (Actual)
May 19, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TiroNod
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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