Trial Outcomes & Findings for Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules (NCT NCT03535974)
NCT ID: NCT03535974
Last Updated: 2020-05-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
after 6 weeks of administration of the supplement and placebo
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
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
|
Sequence P-AI: Placebo Then Active Ingredient (Spirulina)
Placebo administration for 6 weeks bid; afterwards Active Ingredient (Spirulina) for 6 weeks bid
|
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
|
|---|---|---|---|
|
First Intervention Weeks 0-6 (V1-V2)
STARTED
|
14
|
19
|
5
|
|
First Intervention Weeks 0-6 (V1-V2)
COMPLETED
|
12
|
17
|
5
|
|
First Intervention Weeks 0-6 (V1-V2)
NOT COMPLETED
|
2
|
2
|
0
|
|
Second Intervention Weeks 6-12 (V2-V3)
STARTED
|
12
|
17
|
5
|
|
Second Intervention Weeks 6-12 (V2-V3)
COMPLETED
|
12
|
17
|
5
|
|
Second Intervention Weeks 6-12 (V2-V3)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
Sequence P-AI: Placebo Then Active Ingredient (Spirulina)
Placebo administration for 6 weeks bid; afterwards Active Ingredient (Spirulina) for 6 weeks bid
|
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
|
|---|---|---|---|
|
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
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
Baseline characteristics by cohort
| Measure |
AI-P Sequence (12)
n=12 Participants
Participants who received AI initially (first six weeks, V1 and V2) and P afterwards
|
P-AI Sequence (17)
n=17 Participants
Participants who received placebo (P) initially (first six weeks, V1 and V2) and AI afterwards
|
AI-AI Sequence (5)
n=5 Participants
Participants who received AI initially (first six weeks, V1 and V2) and AI afterwards
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
55.58 years
STANDARD_DEVIATION 7.03 • n=5 Participants
|
52.12 years
STANDARD_DEVIATION 15.26 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 15 • n=5 Participants
|
53.44 years
STANDARD_DEVIATION 12.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Surface of Thyroid Nodules
|
4.18 cm^2
STANDARD_DEVIATION 3.45 • n=5 Participants
|
4.298 cm^2
STANDARD_DEVIATION 3.01 • n=7 Participants
|
5.18 cm^2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
4.387 cm^2
STANDARD_DEVIATION 3.139 • n=4 Participants
|
PRIMARY outcome
Timeframe: after 6 weeks of administration of the supplement and placeboPopulation: 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)
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
Outcome measures
| Measure |
Preparation With Spirulina
n=17 Participants
6 weeks bid Preparation with Spirulina
Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules decrease of 19.88% (mean) +/- 15.55 (SD)
|
Placebo
n=17 Participants
6 weeks bid Placebo
Placebo: Placebo administration for 6 weeks bid decrease of 9.21% (mean) +/- 14.29 (SD)
|
|---|---|---|
|
Percent Change in Area of Thyroid Nodules
|
-19.98 percentage change
Standard Deviation 15.55
|
-9.31 percentage change
Standard Deviation 14.29
|
POST_HOC outcome
Timeframe: after 12 weeks of administration of the supplement and placeboPopulation: The total number (instances) of 6 weeks administrations of either AI (n=39) or 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
Outcome measures
| Measure |
Preparation With Spirulina
n=39 Participants
6 weeks bid Preparation with Spirulina
Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules decrease of 19.88% (mean) +/- 15.55 (SD)
|
Placebo
n=29 Participants
6 weeks bid Placebo
Placebo: Placebo administration for 6 weeks bid decrease of 9.21% (mean) +/- 14.29 (SD)
|
|---|---|---|
|
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
|
0.178 cm^2
Standard Deviation 0.515
|
Adverse Events
Preparation With Spirulina
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preparation With Spirulina
n=34 participants at risk
6 weeks bid Preparation with Spirulina
Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules
0 adverse reactions
|
Placebo
n=29 participants at risk
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
|
|---|---|---|
|
Immune system disorders
allergic reaction while on placebo
|
0.00%
0/34 • 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)
|
3.4%
1/29 • Number of events 1 • 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)
|
Other adverse events
| Measure |
Preparation With Spirulina
n=34 participants at risk
6 weeks bid Preparation with Spirulina
Preparation with Spirulina: Preparation with Spirulina to ameliorate the size of benign thyroid nodules
0 adverse reactions
|
Placebo
n=29 participants at risk
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
|
|---|---|---|
|
Immune system disorders
allergic reaction while on placebo
|
0.00%
0/34 • 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)
|
3.4%
1/29 • Number of events 1 • 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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place