N/A
Completed N=38
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
Source: ClinicalTrials.gov NCT03535974 ↗Enrolled (actual)
38
Serious AEs
1.6%
Results posted
May 2020
Primary outcomePrimary: Percent Change in Area of Thyroid Nodules — -19.98; -9.31 percentage change — p=0.047
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Area of Thyroid Nodules |
-19.98; -9.31 | 0.047 sig |
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. Informational only — not medical advice.