Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
Sponsored by Fundatia Bio-Forum
About this trial
Last updated 5 years ago
Study ID
TiroNod
Status
Completed
Type
Interventional
Phase
N/A
Placebo
Yes
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 7 years ago
What is this trial about?
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.
What are the participation requirements?
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