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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|