N/A
N=38
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
Benign Thyroid Nodule
Bottom Line
View on ClinicalTrials.gov: NCT03535974 ↗Enrolled (actual)
38
Serious AEs
1.6%
Results posted
May 2020
Primary outcome: Primary: Percent Change in Area of Thyroid Nodules — -19.98; -9.31 percentage change — p=0.047
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preparation with Spirulina (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundatia Bio-Forum
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Area of Thyroid Nodules |
-19.98; -9.31 | 0.047 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03535974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.