Table 3.

Completed and ongoing clinical trials testing the efficacy of diindolylmethane in breast cancer prevention^a

Study title	Clinicaltrial.gov identifier	Principal investigator	Purpose	Intervention	Date of study completion	Publication
Phase I ascending single dose pharmacokinetics and safety study of 3,3′ diindolylmethane	NCT00784394	A. Hurwitz	Study the side effects and best dose of DIM in preventing cancer in healthy volunteers	Single-dose DIM (BR-DIM); response observed over 24 h	October 2009	Reed et al. (2008)79
Phase 1 multiple-dose safety, pharmacokinetic, and drug interaction clinical study of nutritional-grade, absorption-enhanced DIM (BR-DIM)	NCT00392652	G. Reed	Study the side effects and best dose of DIM in healthy volunteers	Low- and higher-dose BR-DIM twice daily for 4 wk	October 2009	N/A
The potential for oral DIM supplementation to increase the production of the BRCA1 protein in BRCA1 mutation carriers	NCT01022333	S.A. Narod	Determine whether there is potential for oral DIM supplementation to result in increased production of BRCA1 protein in BRCA1 mutation carriers	300 mg of DIM (BR-DIM) daily for 6 wk	July 2010	Nikitina et al. (2015)83
Effect of cruciferous vegetables or cruciferous supplement on urinary estrogen metabolites in premenopausal women	NCT01726127	S.A. Tanumihardjo	Evaluate ratio of urinary estrogen metabolites in healthy premenopausal women	Consumption of 40 g of broccoli or Brussels sprouts daily for 8 wk, followed by Cruciferous Complete supplement for 8 wk	July 2015	N/A
Evaluation of diindolylmethane supplementation to modulate tamoxifen efficacy in breast cancer: the diindolylmethane efficacy study	NCT01391689	C. Thomson	Phase II/III trial to study how well DIM works and to compare DIM with placebo in treating patients with breast cancer	DIM (BR-DIM) orally twice daily for ≈36 mo	September 2016 (estimated)	N/A
A nutritional intervention to decrease breast density among female BRCA carriers – a prospective clinical trial	NCT02197000	D. Margel	Determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers over a period of 2 y	100 mg of DIM-Avail (nutritional supplement) once daily for 24 mo	January 2018 (estimated)	N/A

Abbreviations: BR-DIM, BioResponse diindolylmethane; DIM, diindolylmethane; Q, quartiles; N/A, not available.

^aInformation obtained from clinicaltrials.gov on February 4, 2016.