Chronic Kidney DiseasePhase 2NCT01088776
Omega-3 Fatty Acid Supplementation in Children
A Phase 2 study testing n-3 Fatty Acid supplement in people with Chronic Kidney Disease and Hypertriglyceridemia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Children with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD), occurs early in the progression of kidney failure; timely identification and intervention is prudent. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertriglyceridemia
- What is being tested?
- n-3 Fatty Acid supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Mar 2016
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age at randomization: 2.0-17.4 years old (stratified by age: 2-8 yr, 9-13 yr, 14-17.4 yr)
- CKD stages 3 or 4 (GFR:15-59 ml/min/1.73 m2)
- established and stable in the CKD 3 and 4 Program for a minimum of 3 months
- fasting serum TG 95th percentile for age and gender 2 on more than or equal to 2 occasions
Who cannot join
- allergy to fish, corn, soybean
- anti-coagulant or anti-platelet drugs (heparin, warfarin, therapeutic NSAIDs) or herbal products (ginko, garlic, feverfew, ginger and ginseng) known to prolong bleeding
- currently undergoing treatment for dyslipidemia
- use of dietary supplements containing n-3FA
- children with Nephrotic Syndrome, on dialysis, or transplanted
- planned surgery, dialysis or transplantation within the next 7 months
Show all 17Show fewer
- children with diabetes
- bleeding and clotting disorders:
- thrombocytopenia (platelet count <100 x 109/L), including ITP, TTP
- Von Willebrands disease
- hemophilia
- thrombophilia
- vitamin K deficiency
- severe liver disease
- unstable patients with shock which can lead to DIC (disseminated intravascular coagulation)
- active Henoch Schonlein Purpura
- hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease
Children with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD), occurs early in the progression of kidney failure; timely identification and intervention is prudent. Currently, there is no known effective therapy for hypertriglyceridemia, the most common lipid abnormality. n-3FA, in doses ranging from 2-6 g/day have effectively lowered elevated triglyceride (TG) levels by 20-50% in a variety of adult populations; however, their use in children with CKD has not been tested in a randomized controlled fashion. This study will provide important information on the safety, efficacy and tolerance of n-3FA in lowering elevated TG levels in children and adolescents with CKD.
Read the detailed description
Following counseling on dietary and lifestyle changes to lower triglyceride levels, and a period of applying these modifications, children will be assigned in a random fashion to take either fish oil supplements or a placebo (soybean/corn oil) for 8 weeks. After this 8-week treatment period, children will not take a supplement for 4 weeks and then will be assigned the alternate product (fish oil or placebo) for another 8 weeks. Our main interest is to see whether there is a larger decrease in triglyceride levels after taking the fish oil supplement compared to the placebo.
The primary objective of this study is to determine whether omega-3 fatty acid supplements, given at therapeutic dosages over an 8-week period, significantly decrease elevated serum TG in children with CKD;
The secondary objectives of this study are:
- To evaluate the effect of n-3 fatty acid supplements on total-, LDL-, and HDL-cholesterol; ii. To determine whether n-3 fatty acid supplements are well tolerated by our study participants; and iii. To test whether TG-lowering effects are sustained up to 4 weeks after stopping supplements.
- Conditions
- Chronic Kidney Disease, Hypertriglyceridemia
- Being tested
- n-3 Fatty Acid supplement, Placebo
- Keywords
- CKD, hypertriglyceridemia, Fatty Acid Supplementation, Children, Omega-3
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 Fatty Acid supplementDietary supplement
Children will be prescribed 1600-1800 mg EPA + DHA per m2 Body Surface Area, to a maximum of the upper limit of the age-appropriate range recommended by Health Canada.
Each n-3FA gel capsule (1000 mg) will contain 400 mg EPA and 200 mg DHA derived from the oil of wild anchovies and sardines. A smaller gel capsule (500 mg; 200 mg EPA + 100 mg DHA) will be available for children unable to swallow large solid medication and a flavored liquid formulation, containing a similar proportion of EPA + DHA (2200 mg fish oil concentrate from anchovies and sardines, 750 mg EPA, 375 mg DHA per ½ teaspoon), will be available for use in toddlers and older children unable to swallow gel capsules.
PlaceboDietary supplement
The placebo, identical in opaque appearance and citrus-flavored taste, will contain a 50:50 blend of soybean and corn oil for both gel capsule (2 sizes) and liquid formulations.
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | Not described Receives: Dietary Supplement: n-3 Fatty Acid supplement |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Lipid Profiles(TG levels)
Measured: Week 1,4,12,16,24 and 28
Secondary outcomes (4)
Platelet aggregation
Measured: Week 1,4,12,16,24 and 28
CBC
Measured: Week 1,4,12,16,24 and 28
Cholesterol Levels (LDL and HDL)
Measured: Week 1,4,12,16,24 and 28
Tolerability of n-3 fatty acid supplements by our participants
Sustainability of TG-lowering effects up to 4 weeks after stopping supplements
Measured: Week 1,4,12,16,24 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Harvey, The Hospital for Sick Children
- Investigators
- Donna Secker, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088776
- Sponsor's protocol ID
- 1000012569
- Status last verified
- Oct 2016
- First submitted
- 16 Mar 2010
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01088776
- Acronym / sponsor ID
- 1000012569
- Conditions
- Chronic Kidney Disease, Hypertriglyceridemia
- Keywords
- CKD, hypertriglyceridemia, Fatty Acid Supplementation, Children, Omega-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Mar 2010 (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.
Children with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD), occurs early in the progression of kidney failure; timely identification and intervention is prudent. Currently, there is no known effective therapy for hypertriglyceridemia, the most common lipid abnormality. n-3FA, in doses ranging from 2-6 g/day have effectively lowered elevated triglyceride (TG) levels by 20-50% in a variety of adult populations; however, their use in children with CKD has not been tested in a randomized controlled fashion. This study will provide important information on the safety, efficacy and tolerance of n-3FA in lowering elevated TG levels in children and adolescents with CKD.
Detailed description
Following counseling on dietary and lifestyle changes to lower triglyceride levels, and a period of applying these modifications, children will be assigned in a random fashion to take either fish oil supplements or a placebo (soybean/corn oil) for 8 weeks. After this 8-week treatment period, children will not take a supplement for 4 weeks and then will be assigned the alternate product (fish oil or placebo) for another 8 weeks. Our main interest is to see whether there is a larger decrease in triglyceride levels after taking the fish oil supplement compared to the placebo.
The primary objective of this study is to determine whether omega-3 fatty acid supplements, given at therapeutic dosages over an 8-week period, significantly decrease elevated serum TG in children with CKD;
The secondary objectives of this study are:
- To evaluate the effect of n-3 fatty acid supplements on total-, LDL-, and HDL-cholesterol; ii. To determine whether n-3 fatty acid supplements are well tolerated by our study participants; and iii. To test whether TG-lowering effects are sustained up to 4 weeks after stopping supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: n-3 Fatty Acid supplement |
| Control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age at randomization: 2.0-17.4 years old (stratified by age: 2-8 yr, 9-13 yr, 14-17.4 yr)
- CKD stages 3 or 4 (GFR:15-59 ml/min/1.73 m2)
- established and stable in the CKD 3 and 4 Program for a minimum of 3 months
- fasting serum TG 95th percentile for age and gender 2 on more than or equal to 2 occasions
Key exclusion criteria (17 listed)
- allergy to fish, corn, soybean
- anti-coagulant or anti-platelet drugs (heparin, warfarin, therapeutic NSAIDs) or herbal products (ginko, garlic, feverfew, ginger and ginseng) known to prolong bleeding
- currently undergoing treatment for dyslipidemia
- use of dietary supplements containing n-3FA
- children with Nephrotic Syndrome, on dialysis, or transplanted
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 |
|---|---|---|
| n-3 Fatty Acid supplementChildren will be prescribed 1600-1800 mg EPA + DHA per m2 Body Surface Area, to a maximum of the upper limit of the age-appropriate range recommended by Health Canada. Each n-3FA gel capsule (1000 mg) will contain 400 mg EPA and 200 mg DHA derived from the oil of wild anchovies and sardines. A smaller gel capsule (500 mg; 200 mg EPA + 100 mg DHA) will be available for children unable to swallow large solid medication and a flavored liquid formulation, containing a similar proportion of EPA + DHA (2200 mg fish oil concentrate from anchovies and sardines, 750 mg EPA, 375 mg DHA per ½ teaspoon), will be available for use in toddlers and older children unable to swallow gel capsules. | Dietary supplement | Supplement |
| PlaceboThe placebo, identical in opaque appearance and citrus-flavored taste, will contain a 50:50 blend of soybean and corn oil for both gel capsule (2 sizes) and liquid formulations. | Dietary supplement | Control |
Primary outcome
Fasting Blood Lipid Profiles(TG levels)
Time frame: Week 1,4,12,16,24 and 28
4 secondary outcomes
Platelet aggregation
Time frame: Week 1,4,12,16,24 and 28
CBC
Time frame: Week 1,4,12,16,24 and 28
Cholesterol Levels (LDL and HDL)
Time frame: Week 1,4,12,16,24 and 28
Tolerability of n-3 fatty acid supplements by our participants
Time frame: Week 1,4,12,16,24 and 28
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 21 Oct 2016.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Donna Secker, PhD, RD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing n-3 Fatty Acid supplement in people with Chronic Kidney Disease and Hypertriglyceridemia, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 17 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 21 Oct 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fasting Blood Lipid Profiles(TG levels) (time frame: Week 1,4,12,16,24 and 28). 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 21 Oct 2016.