Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2018-12-21

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Benign Thyroid Nodule

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Preparation with Spirulina

6 weeks bid Preparation with Spirulina

Group Type ACTIVE_COMPARATOR

Preparation with Spirulina

Intervention Type DIETARY_SUPPLEMENT

Preparation with Spirulina to ameliorate the size of benign thyroid nodules

Placebo

6 weeks bid Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo administration for 6 weeks bid

Interventions

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Preparation with Spirulina

Preparation with Spirulina to ameliorate the size of benign thyroid nodules

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo administration for 6 weeks bid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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