NCT02676336

Brief Summary

This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of effectiveness.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

February 3, 2016

Last Update Submit

July 9, 2018

Conditions

Fibrocystic Breast Condition (FBC)

Keywords

FBCcyclic mastalgiabreast discomfort

Outcome Measures

Primary Outcomes (1)

  • Change in self assessed cyclic breast discomfort

    After 6 months of active treatment with molecular iodine (I2) compared to placebo

Study Arms (3)

Violet™ Iodine

ACTIVE COMPARATOR

3mg molecular iodine (I2) daily

Dietary Supplement: Violet™ Molecular Iodine (I2)

Placebo

PLACEBO COMPARATOR

3mg placebo daily

Other: Placebo

Cross-over

ACTIVE COMPARATOR

Subjects on placebo will be offered 3 months of active post-treatment

Dietary Supplement: Violet™ Molecular Iodine (I2)

Interventions

Violet™ Molecular Iodine (I2)DIETARY_SUPPLEMENT
Cross-overViolet™ Iodine
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy premenopausal females ≥ 18 years of age
  • BMI 20.0 - 29.9 kg/m2 (± 1 kg/m2)
  • Females of childbearing potential must agree to use a reliable and consistent method of birth control in the Investigator's opinion, excluding depot contraceptives and Explanon, and have a negative urine pregnancy test result. Hormonal contraceptives such as oral contraceptives, birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing) are all acceptable as long as the subject is on a stable dose and agrees not to change during the study period
  • No apparent health conditions that in the investigator's opinion would interfere with study participation, compliance or interpretation of endpoints or would not be in the best interest of the subject
  • Moderate to severe cyclic breast discomfort of at least 4 days per month (discomfort ≥4 on a 0-10 scale)
  • No known medical or psychological condition that in the investigator's opinion could interfere with study participation
  • Agrees to comply with all study related procedures and visits including access to a smartphone (Android or iOS) and ability to enter daily diary information via a smart phone app
  • Capable of reading and understanding study related materials (in English or French) and has given voluntary, written, informed consent to participate in the study

You may not qualify if:

  • Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
  • Perimenopausal or irregular menstrual cycles
  • Women who have had an oophorectomy
  • Known thyroid condition or currently taking any thyroid medications
  • Prior bariatric surgery or other interventions or medications that might affect gastric pH
  • Use of iodine supplementation, Tamoxifen, Lupron, or Danazol, in the last 6 months
  • Clinically significant abnormal laboratory results at Screening
  • Breast implant surgeries that have not fully healed or have ongoing problems associated with the implant (i.e. seroma, infection etc.)
  • Planned elective surgeries to occur during participation in the study
  • Known allergy or sensitivity to study product ingredients (e.g. Iodine)
  • History of alcohol or drug abuse within the past year
  • Use of medicinal marijuana within the past year
  • Participation in a clinical research trial within 30 days prior to randomization or plans to participate in any other study during the next 11 months
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures, may confound interpretation of study outcome measures (such as another condition) or which may pose significant risk to the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KGK Synergize

Orlando, Florida, 32806, United States

Location

KGK Synergize

London, Ontario, N6A5R8, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

US(1)CA(1)