FH Detection in Children by Salivary Test

Hyperlipoproteinemia Type II Clinical Trial

— DEPEDIACOL  

Official title:

Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261803
• Other study ID #: 69HCL19_0861
• Secondary ID: 2019-A03076-51
• Status: Completed
• Start date: February 18, 2020
• Est. completion date: August 26, 2020

Study information

• Verified date: September 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria :

• children under 18 years old, with familial hypercholesterolemia

• children under 18 years old, intending surgery

• being able to spit

Exclusion Criteria:

• poor dental health

• for control patients: to have a known cholesterol disease

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemia Type II
• Hyperlipoproteinemias

Intervention

Biological:
• salivary sample
spit of saliva in a tube
• blood test
2millilitter blood test

Locations

Country	Name	City	State
France	Hospices Civils de Lyon gastro-enterological hepatology and nutrition	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	salivary cholesterol concentration	the sample will be obtained during one visit non dedicated to this study (following-visit in nutrition for hypercholesterolemia children and before surgery for control children), the swabs of all the 60 patients will be used in two different methods of enzymatic tests.	Day 1