Benign Thyroid Nodule
Conditions
Brief 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. 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
Interventions
DIETARY_SUPPLEMENTPreparation with Spirulina
Preparation with Spirulina to ameliorate the size of benign thyroid nodules
DIETARY_SUPPLEMENTPlacebo
Placebo administration for 6 weeks bid
Sponsors
Fundatia Bio-Forum
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Area of Thyroid Nodules | 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 |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AI-P Sequence (12) Participants who received AI initially (first six weeks, V1 and V2) and P afterwards | 12 |
| P-AI Sequence (17) Participants who received placebo (P) initially (first six weeks, V1 and V2) and AI afterwards | 17 |
| AI-AI Sequence (5) Participants who received AI initially (first six weeks, V1 and V2) and AI afterwards | 5 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First Intervention Weeks 0-6 (V1-V2) | Adverse Event | 0 | 1 | 0 |
| First Intervention Weeks 0-6 (V1-V2) | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | P-AI Sequence (17) | AI-AI Sequence (5) | Total | AI-P Sequence (12) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 6 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 3 Participants | 28 Participants | 10 Participants |
| Age, Continuous | 52.12 years STANDARD_DEVIATION 15.26 | 52.8 years STANDARD_DEVIATION 15 | 53.44 years STANDARD_DEVIATION 12.63 | 55.58 years STANDARD_DEVIATION 7.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 5 Participants | 34 Participants | 12 Participants |
| Sex: Female, Male Female | 16 Participants | 3 Participants | 29 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 5 Participants | 2 Participants |
| Surface of Thyroid Nodules | 4.298 cm^2 STANDARD_DEVIATION 3.01 | 5.18 cm^2 STANDARD_DEVIATION 3.4 | 4.387 cm^2 STANDARD_DEVIATION 3.139 | 4.18 cm^2 STANDARD_DEVIATION 3.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 29 |
| other Total, other adverse events | 0 / 34 | 1 / 29 |
| serious Total, serious adverse events | 0 / 34 | 1 / 29 |
Outcome results
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
Time frame: after 6 weeks of administration of the supplement and placebo
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preparation With Spirulina | Percent Change in Area of Thyroid Nodules | -19.98 percentage change | Standard Deviation 15.55 |
| Placebo | Percent Change in Area of Thyroid Nodules | -9.31 percentage change | Standard Deviation 14.29 |
p-value: 0.047t-test, 2 sided
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
Time frame: after 12 weeks of administration of the supplement and placebo
Population: The total number (instances) of 6 weeks administrations of either AI (n=39) or P (n=29)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preparation With Spirulina | Mean Change in Nodule Areas, All Administrations of 6 Weeks Each (n=68), AI (n=39) Versus P (n=29) | 0.611 cm^2 | Standard Deviation 0.933 |
| Placebo | Mean Change in Nodule Areas, All Administrations of 6 Weeks Each (n=68), AI (n=39) Versus P (n=29) | 0.178 cm^2 | Standard Deviation 0.515 |