CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
Vitamin D ergocalciferol +4 moredrug
Likely dose
Vitamin D ergocalciferol 50,000 unitfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01320722
NCT01320722Phase 3Completed

Modifiable Effectors of Renin System Activation: Treatment Evaluation (MODERATE)

Brigham and Women's Hospital·interventional·Posted Mar 22, 2011·Updated Jun 29, 2017

In Brief

A Phase 3 clinical trial evaluating Vitamin D ergocalciferol, Probenecid, and 2 other interventions for Renal Function and 4 related conditions. Completed, enrolled 242 participants across 1 site.

Detailed Summary

The investigators hypothesize that, among non-hypertensive overweight and obese individuals, treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system (RAS) activation, improve endothelial function, and lower blood pressure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.3 years ago

Interventions

Vitamin D ergocalciferoldrug

50,000 unit soft gel capsule once per week for 8 weeks

Probeneciddrug

500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total)

Allopurinoldrug

300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total)

Placebodrug

Placebo soft gel once per week for 8 weeks

Placebodrug

Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total)