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This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential effects of dietary supplement Violetâ„¢ Iodine on breast health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Violetâ„¢ Iodine | Active Comparator | 3mg molecular iodine (I2) daily |
|
| Placebo | Placebo Comparator | 3mg placebo daily |
|
| Cross-over | Active Comparator | Subjects on placebo will be offered 3 months of active post-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Violetâ„¢ Molecular Iodine (I2) | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self assessed cyclic breast discomfort | After 6 months of active treatment with molecular iodine (I2) compared to placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize | Orlando | Florida | 32806 | United States | ||
| KGK Synergize |
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| Other |
|
| London |
| Ontario |
| N6A5R8 |
| Canada |