Benign Thyroid NoduleESSAYNCT03535974
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
A study testing Preparation with Spirulina in people with Benign Thyroid Nodule, run by Fundatia Bio-Forum at 1 site in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Thyroid Nodule
- What is being tested?
- Preparation with Spirulina
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteRomania
- Study dates
- 15 May 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- suspicion of malignancy / shown
- autoimmune disease
- abnormal thyroid function
- Wilson disease
- contraception with intrauterine device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Benign Thyroid Nodule
- Being tested
- Preparation with Spirulina, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparation with SpirulinaDietary supplement
Preparation with Spirulina to ameliorate the size of benign thyroid nodules
PlaceboDietary supplement
Placebo administration for 6 weeks bid
| Study group | Role | What they receive |
|---|---|---|
| Preparation with Spirulina | Active comparator | 6 weeks bid Preparation with Spirulina Receives: Dietary Supplement: Preparation with Spirulina |
| Placebo | Placebo comparator | 6 weeks bid Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Area of Thyroid Nodules
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
Measured: after 6 weeks of administration of the supplement and placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start15 May 2018
- Primary completion20 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundatia Bio-Forum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corin Badiu, M.D., Principal investigator, Institutul Parhon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535974
- Sponsor's protocol ID
- TiroNod
- Acronym
- ESSAY
- Status last verified
- May 2020
- First submitted
- 2 May 2018
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stancioiu F, Mihai D, Papadakis GZ, Tsatsakis A, Spandidos DA, Badiu C. Treatment for benign thyroid nodules with a combination of natural extracts. Mol Med Rep. 2019 Sep;20(3):2332-2338. doi: 10.3892/mmr.2019.10453. Epub 2019 Jul 1.
PubMed 31322200
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT03535974
- Acronym / sponsor ID
- ESSAY / TiroNod
- Conditions
- Benign Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fundatia Bio-ForumUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preparation with Spirulina | Active comparator | Dietary Supplement: Preparation with Spirulina6 weeks bid Preparation with Spirulina |
| Placebo | Placebo comparator | Dietary Supplement: Placebo6 weeks bid Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- suspicion of malignancy / shown
- autoimmune disease
- abnormal thyroid function
- Wilson disease
- contraception with intrauterine device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preparation with SpirulinaPreparation with Spirulina to ameliorate the size of benign thyroid nodules | Dietary supplement | Preparation with Spirulina |
| PlaceboPlacebo administration for 6 weeks bid | Dietary supplement | Placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31322200Stancioiu F, Mihai D, Papadakis GZ, Tsatsakis A, Spandidos DA, Badiu C. Treatment for benign thyroid nodules with a combination of natural extracts. Mol Med Rep. 2019 Sep;20(3):2332-2338. doi: 10.3892/mmr.2019.10453. Epub 2019 Jul 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corin Badiu, M.D. principal investigator
Institutul Parhon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparation with Spirulina in people with Benign Thyroid Nodule, run by Fundatia Bio-Forum at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Area of Thyroid Nodules (time frame: after 6 weeks of administration of the supplement and placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03535974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.