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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: Recruiting study of Mitochondrial Disorders and Leigh Disease, sponsored by National Human Genome Research Institute (NHGRI).
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
By developing an understanding of immune dysfunction, targets for rational therapies may be developed for this patient population.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2012-12-31 |
What NCT01780168 shows while recruiting
NCT01780168 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 4 conditions, with Mitochondrial Disorders appearing as the primary indexed condition, and to 0 interventions.
NCT01780168 reports a single indexed study location in 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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