HemodialysisNCT00431899
Effects of Omega 3 in Hemodialysis Patients
A study testing fish oil supplementation in people with Hemodialysis and End Stage Renal Disease, run by Laboratoire Régional de Nutrition Humaine at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease
- What is being tested?
- fish oil supplementation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- May 2003to Nov 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemodialysis at least 6 months duration end stage renal disease
Who cannot join
- - Age < 18 y ou > 75 y
- Hemodialysis < 6 months
- Diabetes, obesity
- allergy to fish
- Asthma
- glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin
Show all 14Show fewer
- erythropoïetin < 3 months
- Cancer
- Hemoglobin < 11 g/l
- disease < 1 month
- pregnancy
- respiratory insufficiency
- intensive sport practice
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effets of Fish Oil on Metabolic Fate of an Oral Glucose Load in Patients With End Stage Renal Disease Undergoing Hemodialysis
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.
- Conditions
- Hemodialysis, End Stage Renal Disease
- Being tested
- fish oil supplementation
- Keywords
- nutrition, omega 3 fatty acids, insulin resistance
- Medical subject headings
- Kidney Failure, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oil supplementationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucose utilization
glucose-induced thermogenesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startMay 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- Laboratoire Régional de Nutrition Humaine
- Sponsor type
- University, hospital or other
- Investigators
- Jacques Delarue, MD,PhD, Principal investigator, CHU Cavale Blanche F-29200 Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431899
- Sponsor's protocol ID
- HDW3
- Status last verified
- Feb 2007
- First submitted
- 3 Feb 2007
- Last updated
- 3 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effets of Fish Oil on Metabolic Fate of an Oral Glucose Load in Patients With End Stage Renal Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT00431899
- Acronym / sponsor ID
- HDW3
- Conditions
- Hemodialysis, End Stage Renal Disease
- Keywords
- nutrition, omega 3 fatty acids, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- Laboratoire Régional de Nutrition HumaineUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Nov 2003
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemodialysis at least 6 months duration end stage renal disease
Key exclusion criteria (14 listed)
- - Age < 18 y ou > 75 y
- Hemodialysis < 6 months
- Diabetes, obesity
- allergy to fish
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish oil supplementation | Behavioural | – |
Primary outcome
plasma glucose utilization
glucose-induced thermogenesis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Delarue, MD,PhD principal investigator
CHU Cavale Blanche F-29200 Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil supplementation in people with Hemodialysis and End Stage Renal Disease, run by Laboratoire Régional de Nutrition Humaine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma glucose utilization. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.