Soy Isoflavones and Breast Cancer Risk Reduction
|ClinicalTrials.gov Identifier: NCT00204490|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: isoflavones Dietary Supplement: carbohydrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Research pharmacist dispensed study pills according to a pre-generated randomization list and were blinded to all other aspects of the study protocol.
Subjects, research staff, investigators, and statistician all were blinded to treatment assignment.
|Official Title:||Mammographic Density and Soy Isoflavones|
|Actual Study Start Date :||April 2004|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Dietary Supplement: isoflavones
soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.
Other Name: Isoflavone pill
Placebo Comparator: 2
Dietary Supplement: carbohydrate
carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.
Other Name: Sugar pill
- Breast density [ Time Frame: one or two years after dietary supplements ]
- bone density [ Time Frame: one or two years after dietary supplement ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204490
|United States, Texas|
|General Clinical Reserach Center, The University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0264|
|Principal Investigator:||Lee-Jane W Lu, Ph.D.||The University of Teas Medical Branch|