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NCT06128278 · ClinicalTrials.gov registry record · Phase 2

Acute Equol Supplementation and Vascular Function in Women With and Without CKD

A Phase 2 study of Chronic Kidney Diseases and Women, sponsored by University of Colorado, Denver.

Recruiting
Registry status
Phase 2
Development phase
38
Enrollment target
1
Study location

NCT06128278: Recruiting Phase 2 study of Chronic Kidney Diseases and Women, sponsored by University of Colorado, Denver.

NCT06128278 is a Phase 2 study of Chronic Kidney Diseases and Women that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 38 participants, below the 444-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06128278, a Phase 2 study of Chronic Kidney Diseases and Women, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
Phase 2
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in nephrology focuses on male patients, and studies on women's vascular health are limited. Establishing effective therapies for improving vascular function and reducing CVD risk in women with CKD is a high research priority of the NIH. Equol contributes to improvement in vascular function, mediated in part by its anti-oxidative and anti-inflammatory properties. However, there is no information on the effect of equol on vascular function in women with CKD. The proposed project aims to determine the acute effect (1-hour, 2-hours, and 3-hours post ingestion) of oral equol supplementation on vascular function in postmenopausal women with and without CKD.

Primary Outcome

Flow-mediated dilation of the brachial artery will be performed using ultrasonography and analyzed with a commercially available software package as percent change in diameter from baseline following reactive hyperemia.

Interventions

  • OTHER Placebo
  • DRUG S-equol

Study Locations (1)

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2023-03-07
Est. Completion 2026-12-31
Phase Phase 2
University of Colorado, Denver

1,283 total trials

What NCT06128278 shows while recruiting

NCT06128278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 444-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (91% lower).

The record links to 3 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06128278 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT06128278 about?

NCT06128278 is a clinical study titled "Acute Equol Supplementation and Vascular Function in Women With and Without CKD". The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literatu...

What is the current status of trial NCT06128278?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2023-03-07. Estimated completion is 2026-12-31.

What conditions does trial NCT06128278 study?

This clinical trial studies the following conditions: Chronic Kidney Diseases, Women, Vascular Function.

What interventions are being tested in trial NCT06128278?

The interventions under investigation include: Placebo (OTHER), S-equol (DRUG).

Who is sponsoring clinical trial NCT06128278?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06128278 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Chronic Kidney Diseases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06128278's enrollment target sits among peer trials

38 59th of 73 higher than 15 of 73 other Chronic Kidney Diseases trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06128278, the US trial registry maintained by the National Library of Medicine. NCT06128278 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.