NCT01392313

Brief Summary

The investigators will measure renal function in subjects ingesting carnitine to determine if the product alters renal function.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

July 11, 2011

Last Update Submit

July 19, 2018

Conditions

Carnitine Ingestion

Keywords

carnitine, kidney

Outcome Measures

Primary Outcomes (1)

  • Iohexol clearance

    Iohexol clearance will be measured

    1 month

Study Arms (2)

Carnitine

EXPERIMENTAL

Participants will be given Creatinine supplements

Dietary Supplement: Carnitine

Placebo

PLACEBO COMPARATOR

participants will be given creatinine placebo

Dietary Supplement: Placebo

Interventions

CarnitineDIETARY_SUPPLEMENT

Carnitine Ingestion

Carnitine
PlaceboDIETARY_SUPPLEMENT

Carnitine placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • carnitine ingestion

You may not qualify if:

  • renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Joel Neugarten, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

US(1)