Trials / Completed
CompletedNCT03152097
Targeting FMO-Mediated TMAO Formation in Kidney Disease (TMAO) Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The project will investigate the modulation of flavin-containing monooxygenase (FMO) formation of the CVD risk factor trimethylamine-N-oxide (TMAO) in patients with kidney disease.
Detailed description
Twelve patients with stage 3 to 4 kidney disease will receive an intervention for four weeks and a matching placebo in a crossover study design. Reduction of serum TMAO from baseline to end of intervention will be the primary endpoint.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Commercially available Diindolylmethane | Commercially available Diindolylmethane is a compound derived from cruciferous vegetables (e.g. broccoli) |
| OTHER | Placebo | A matching placebo capsule will be compounded by the UPMC Investigational Drug Service |
Timeline
- Start date
- 2018-03-30
- Primary completion
- 2019-04-18
- Completion
- 2019-08-30
- First posted
- 2017-05-12
- Last updated
- 2019-09-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03152097. Inclusion in this directory is not an endorsement.