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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00431899
Other study ID # HDW3
Secondary ID
Status Completed
Phase N/A
First received February 3, 2007
Last updated March 2, 2016
Start date May 2003
Est. completion date November 2003

Study information

Verified date February 2007
Source Laboratoire Régional de Nutrition Humaine
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of the study was to determine the effects of a 3-week fish oil oral supplementation on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis patients.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date November 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- hemodialysis at least 6 months duration end stage renal disease

Exclusion Criteria:

- - Age < 18 y ou > 75 y

- Hemodialysis < 6 months

- Diabetes, obesity

- allergy to fish

- Asthma

- glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin

- erythropoïetin < 3 months

- Cancer

- Hemoglobin < 11 g/l

- disease < 1 month

- pregnancy

- respiratory insufficiency

- intensive sport practice

- refusal

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Intervention

Behavioral:
fish oil supplementation


Locations

Country Name City State
France Laboratoire Régional de Nutrition Humaine Brest

Sponsors (1)

Lead Sponsor Collaborator
Laboratoire Régional de Nutrition Humaine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma glucose utilization
Primary glucose-induced thermogenesis
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