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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preparation with Spirulina | Active Comparator | 6 weeks bid Preparation with Spirulina |
|
| Placebo | Placebo Comparator | 6 weeks bid Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preparation with Spirulina | Dietary Supplement | Preparation with Spirulina to ameliorate the size of benign thyroid nodules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | after 6 weeks of administration of the supplement and placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corin Badiu, M.D. | Institutul Parhon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundatia Bio-Forum | Bucharest | Bucharest | 040245 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31322200 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence AI-P: Active Ingredient (Spirulina) Then Placebo | Patients in this sequence first received 6 weeks the Active Ingredient (Spirulina) bid, and afterwards 6 weeks Placebo bid |
| FG001 | Sequence P-AI: Placebo Then Active Ingredient (Spirulina) | Placebo administration for 6 weeks bid; afterwards Active Ingredient (Spirulina) for 6 weeks bid |
| FG002 | Sequence AI-AI (Active Ingredient, Then Active Ingredient) | Patients receive Active Ingredient (AI) for 6 weeks bid, and afterwards Active Ingredient (AI) for 6 weeks bid |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Weeks 0-6 (V1-V2) |
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| Second Intervention Weeks 6-12 (V2-V3) |
|
For the primary outcome we compared the effect of the AI vs P after the initial 6 weeks of the study (V1-V2). For this we combined the AI-AI sequence and AI-P sequence in one arm, and compared with the P-AI sequence arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | AI-P Sequence (12) | Participants who received AI initially (first six weeks, V1 and V2) and P afterwards |
| BG001 | P-AI Sequence (17) | Participants who received placebo (P) initially (first six weeks, V1 and V2) and AI afterwards |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Effects of AI vs P between the two arms is calculated after the first 6 weeks (V1-V2, AI vs P). After 12 weeks (V1-V3) patients in each arm/sequence receive the same treatment in a different sequence (AI+P; vs P+AI) and no difference is expected. A second outcome compares results of all administrations of 6 weeks each of AI (39) and P (29) | Posted | Mean | Standard Deviation | percentage change | after 6 weeks of administration of the supplement and placebo |
|
6 months
One patient who was on multiple medications at enrollment developed a generalized skin eruption with moderate prurit after a few days with the study substance; she interrupted the administration after talking with the investigator and afterwards it was revealed that she was taking placebo All participants who completed the study (n=34) received the AI (active ingredient) and 5 patients out of the 34 (n=29) received the AI-AI sequence, so that only 29 patients received placebo (P)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preparation With Spirulina | 6 weeks bid Preparation with Spirulina Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules 0 adverse reactions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction while on placebo | Immune system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction while on placebo | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Felician Stancioiu | Fundatia Bio-Forum | +40727500402 | felicians11@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2018 | Mar 31, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2018 | Mar 31, 2020 | ICF_001.pdf |
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| Placebo | Dietary Supplement | Placebo administration for 6 weeks bid |
|
| NOT COMPLETED |
|
| BG002 | AI-AI Sequence (5) | Participants who received AI initially (first six weeks, V1 and V2) and AI afterwards |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Surface of Thyroid Nodules | Surface of thyroid nodules in cm^2 | Mean | Standard Deviation | cm^2 |
|
| OG001 | Placebo | 6 weeks bid Placebo Placebo: Placebo administration for 6 weeks bid decrease of 9.21% (mean) +/- 14.29 (SD) |
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|
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| Post-Hoc | Mean Change in Nodule Areas, All Administrations of 6 Weeks Each (n=68), AI (n=39) Versus P (n=29) | Mean modification in the area of the nodules in cm^2, calculated as the difference between the initial and final nodule area after 6 weeks of administration of either AI (total 39 administrations) or P (total 29 administrations), and standard deviation | The total number (instances) of 6 weeks administrations of either AI (n=39) or P (n=29) | Posted | Mean | Standard Deviation | cm^2 | after 12 weeks of administration of the supplement and placebo |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Placebo | 6 weeks bid Placebo Placebo: Placebo administration for 6 weeks bid One patient had a severe allergic reaction while she was on placebo and multiple other medications and withdrew from the study | 0 | 29 | 1 | 29 | 1 | 29 |
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