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NCT01323335 · ClinicalTrials.gov registry record · Phase 1

The Relationship Between Uric Acid and Inflammatory Markers

A Phase 1 study of Healthy Volunteers, sponsored by National Institute on Aging (NIA).

Completed
Registry status
Phase 1
Development phase
97
Enrollment target
1
Study location

NCT01323335: Completed Phase 1 study of Healthy Volunteers, sponsored by National Institute on Aging (NIA).

NCT01323335 is a Phase 1 study of Healthy Volunteers that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 97 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (80% 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

NCT01323335, a Phase 1 study of Healthy Volunteers, has completed, sponsored by National Institute on Aging (NIA).

COMPLETED
Registry status
Phase 1
Development phase
97 participants
Enrollment target
1
Study location

Study Summary

Background: \- Uric acid is a substance found in the blood that may contribute to certain chronic medical conditions and disorders, such as diabetes, insulin resistance, and high blood pressure. High uric acid concentrations have been associated with stroke and heart disease, as well as chronic heart failure. In particular, researchers are interested in determining the relationship between uric acid and inflammatory markers, or chemicals in the blood that can indicate inflammation and other problems with the body. Objectives: * To study the specific effects of changes in uric acid in the body. * To determine whether uric acid contributes to inflammation in the body. Eligibility: \- Healthy individuals between 50 and 75 years of age. Design: * This study will involve four visits: a screening visit, two study visits, and a followup visit. * At the screening visit, participants will have a physical examination, blood and urine tests, and an electrocardiogram. Participants will be divided into two groups based on the existing amount of uric acid in their blood. * Within 7 days of the screening visit, participants will have a full-day study visit with a magnetic resonance imaging scan, followed by a high-fat meal and further blood samples collected over the following 8 hours. * At least 2 days after the first study visit, participants will have the second study visit, which will require a 2-night stay at the National Institutes of Health. Participants will have a metabolism test, and will receive the following infusions based on the groups they were assigned to at the screening visit. * Group A (low uric acid) will receive either uric acid or a placebo. * Group B (moderate to high uric acid) will receive either Rasburicase (a drug that reduces the amount of uric acid in the blood) or a placebo. * After the infusions and related blood tests, participants will have a high-fat meal with further blood and urine samples. * Approximately 2 weeks after the second study v

Conditions Studied

Healthy Volunteers

Interventions

  • DRUG IV Uric Acid
  • DRUG IV Rasburicase

Study Locations (1)

Maryland

  • National Institute of Aging, Clinical Research Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2009-03-31
Est. Completion 2014-01-31
Phase Phase 1
National Institute on Aging (NIA)

131 total trials

What the finished NCT01323335 record still lists

NCT01323335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which IV Uric Acid is the first listed.

NCT01323335 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT01323335 about?

NCT01323335 is a clinical study titled "The Relationship Between Uric Acid and Inflammatory Markers". Background: \- Uric acid is a substance found in the blood that may contribute to certain chronic medical conditions and disorders, such as diabetes, insulin resistance, and high blood pressure. High uric acid concentrations have been associated with stroke and heart disease, as well as chronic hea...

What is the current status of trial NCT01323335?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2009-03-31. Estimated completion is 2014-01-31.

What conditions does trial NCT01323335 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT01323335?

The interventions under investigation include: IV Uric Acid (DRUG), IV Rasburicase (DRUG).

Who is sponsoring clinical trial NCT01323335?

This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01323335 being conducted?

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

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Where NCT01323335's enrollment target sits among peer trials

97 81st of 283 higher than 202 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers 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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Related registry views

Source: ClinicalTrials.gov NCT01323335, the US trial registry maintained by the National Library of Medicine. NCT01323335 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.