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Omega-3 fatty acids supplementation for HIV patients.

- candidate number5702
- NTR NumberNTR1798
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mei-2009
- Secondary IDs2008/50970-8 Fapesp
- Public TitleOmega-3 fatty acids supplementation for HIV patients.
- Scientific TitleEffects of omega-3 fatty acids supplementation for HIV patients on HAART: randomized double-blind placebo-controlled clinical trial.
- hypothesisFatty acids supplementation can:
1. Reduce or prevent triglycerides increase;
2. Reduce inflammatory markers concentration.
- Healt Condition(s) or Problem(s) studiedHIV-positive patients, HAART
- Inclusion criteria1. Adults (20-64 years);
2. Stable antiretroviral therapy for at least 3 months;
3. Blood triglycerides > 100 and < 750 mg/dL;
4. Blood LDL-cholesterol < 160 mg/dL;
5. Blood glucose < 126 mg/dL.
- Exclusion criteria1. Use of fibrates and/or estatins;
2. Use of nutritional supplementation (vitamins and minerals), metformin and or anticoagulant;
3. Severe AIDS or associated diseases.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-mei-2009
- planned closingdate30-mrt-2010
- Target number of participants120
- InterventionsIntervention group: 3 fish oil capsules (1 g each) per day during 24 weeks.

Placebo group: 3 placebo capsules (soy oil) per day during 24 weeks.
- Primary outcome1. Triglycerides;
2. Total cholesterol and fractions (VLDL, LDL, HDL);
3. Apolipoprotein A1;
4. Apolipoprotein B;
5. High sensible C-reactive protein;
6. Tumor necrosis factor-alpha;
7. Interleukin 6;
8. Interleukin-1beta;
9. Ferritin;
10. Fibrinogen;
11. Von Willebrand factor.
- Secondary outcome1. Lymphocytes T count (CD4 and CD8);
2. Viral load;
3. Fasting glycaemia;
4. Insulin;
5. Transferrin;
6. Haemogram;
7. Glutamic-oxalacetic transaminase;
8. Glutamic-pyruvic transaminas;
9. Creatinine;
10. BMI;
11. Waist circumference;
12. Hip circumference;
13. Neck circumference.
- TimepointsBaseline, 3 months and 6 months of supplementation.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT for SCIENTIFIC QUERIES J.M. Oliveira-Menegozzo
- Sponsor/Initiator FAPESP - The State of Sao Paulo Research Foundation
- Funding
(Source(s) of Monetary or Material Support)
FAPESP - The State of Sao Paulo Research Foundation
- PublicationsN/A
- Brief summaryBackground:
The highly active antiretroviral therapy (HAART) regimens have been shown to cause metabolic alterations that are associated with an increased risk of cardiovascular disease.
Evaluate the effects of omega-3 supplementation in Brazilian adult subjects living with HIV/Aids on inflammatory and biochemical profile.
Material and Methods:
120 adult (19-64 years old) subjects in a stable antiretroviral therapy (3 months at least) will be recruited at the HIV-AIDS Clinic (Medical School, University of Sao Paulo, Brazil). The subjects will be randomly assigned to the experimental (3g of fish oil/day) or the placebo group, and supplemented for 24 weeks. Physical active and food intake will be assessed at baseline. Immunologic, nutritional, Inflammatory and biochemical variables will be assessed at baseline, 12 and 24 weeks after supplementation.
- Main changes (audit trail)
- RECORD5-mei-2009 - 15-okt-2010

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