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NCT01780168 · ClinicalTrials.gov registry record

The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism

A clinical trial of Mitochondrial Disorders and Leigh Disease, sponsored by National Human Genome Research Institute (NHGRI).

Recruiting
Registry status
500
Enrollment target
1
Study location

NCT01780168 is a study of Mitochondrial Disorders and Leigh Disease that is actively recruiting participants, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 500 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01780168, a study of Mitochondrial Disorders and Leigh Disease, is actively recruiting participants, sponsored by National Human Genome Research Institute (NHGRI).

RECRUITING
Registry status
500 participants
Enrollment target
1
Study location

Study Summary

The Metabolism, Infection and Immunity (MINI) Study is a longitudinal natural history study at the National Institutes of Health (NIH) that aims to define the relationship between infection, immunity and clinical decline in individuals with mitochondrial disease. Mitochondrial diseases are a group of disorders caused by problems with the cell s ability to produce energy. Infection in individuals with mitochondrial disease can lead to worsening clinical symptoms, particularly neurologic symptoms. Goals: The main goal of our study is to understand the relationship between infection and clinical decline in patients with mitochondrial disease. Mitochondrial diseases can affect many different parts of the body, including the immune system and its ability to respond to infection. Therefore, we perform a comprehensive evaluation of participants including a detailed immunologic assessment. We are not testing any new medicine or procedure to treat or cure IEM or mitochondrial diseases. However, by understanding the relationship between infection and mitochondrial disease, we hope to develop treatments in the future. At the NIH, we are interested in research. Although we do provide advice and care for people enrolled in our study, we are not able to take over the long-term care of participants. To enroll in our study, you (your child) must already have a confirmed diagnosis of a mitochondrial disease. We are not able to provide a "first time" diagnosis or regular metabolic care. What is involved? Once you contact our team members, you will be asked to provide medical records to determine eligibility. Our team will review the records and notify you if you (your child is) eligible to join the study. -Onsite participation: You (your child) will be invited to visit the National Institutes of Health in Bethesda, Maryland. This first visit will typically last 3-5 days. Depending on the level of participation, additional visits may be requested. Our team members will work with

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2012-12-31

What the Registry Record Tells You About NCT01780168

The ClinicalTrials.gov registry entry for NCT01780168 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Mitochondrial Disorders appearing as the primary indexed condition, and to 0 interventions.

NCT01780168 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01780168 about?

NCT01780168 is a clinical study titled "The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism". The Metabolism, Infection and Immunity (MINI) Study is a longitudinal natural history study at the National Institutes of Health (NIH) that aims to define the relationship between infection, immunity and clinical decline in individuals with mitochondrial disease. Mitochondrial diseases are a group o...

What is the current status of trial NCT01780168?

This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2012-12-31.

What conditions does trial NCT01780168 study?

This clinical trial studies the following conditions: Mitochondrial Disorders, Leigh Disease, Oxidative Phosphorylation Deficiencies, Electron Transport Chain Disorders, Mitochondrial.

Who is sponsoring clinical trial NCT01780168?

This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01780168 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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