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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00260299
Other study ID # MKD dietary study
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 2005
Est. completion date January 31, 2016

Study information

Verified date May 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Participants wanted for study of mevalonate kinase deficiency (MKD), mevalonic aciduria, or hyperimmunoglobulinemia with periodic fever syndrome (HIDS).

Patients with MKD (mevalonic aciduria or hyperimmunoglobulinemia with periodic fever syndrome (HIDS)) may be eligible for a research study conducted at Oregon Health & Science University (OHSU) in Portland, Oregon USA. The purpose of the study is to find out more about how these diseases affect body chemistry and health. The researchers also want to find out how cholesterol in the diet affect blood cholesterol and how the body handles cholesterol. This is a short-term and long-term dietary study. The long-term goal of this research is to see if controlling dietary cholesterol can decrease any of the symptoms of the diseases.

The study could involve up to 12 one-week admissions to OHSU over the course of 5 years.


Description:

Participants are admitted to the clinical research center for up to a week per visit. Additional visits at least yearly encouraged. During the week we measure such things as cholesterol absorption, sterol and bile acid synthesis, mevalonate and mevalonate shunt products, isoprenoids, fatty acids, leukotrienes, plasma cholesterol and other sterol levels. Also, the effects of altering dietary cholesterol on plasma 24-S OH-cholesterol, a measure of brain cholesterol turnover, will be evaluated. Studies of body composition/ metabolism/ growth, development, behavior, sleep, feeding, hearing and vision will be carried out to document the phenotype and determine if dietary intervention may be helpful.

The objective of the study is to characterize the metabolic and phenotypic consequences of MKD and study the effects of altering dietary cholesterol in MKD. We hypothesize that some of the phenotypic effects of MKD are due to altered cholesterol metabolism, but that the phenotype is predominantly due to derangements in isoprenoid metabolism.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date January 31, 2016
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Must have documented mevalonate kinase deficiency, mevalonic aciduria, or HIDS

- Must be willing to participate in most research procedures

Exclusion Criteria:

- Unable or unwilling to participate in most research procedures

Study Design


Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the effects of dietary cholesterol changes in MKD on cholesterol and related synthetic pathways blood levels of cholesterol December 2011
Secondary Define genotype, phenotype and response to dietary cholesterol. Determine genotype-therapy correlations. Gene Mutations - 7-dehydrocholesterol levels December 2011
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