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Omega-3 fatty acids supplementation for HIV patients.

Effects of omega-3 fatty acids supplementation for HIV patients on HAART: randomized double-blind placebo-controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20494
Enrollment
120
Registered
2009-05-05
Start date
2009-05-11
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV patients on antiretroviral therapy

Interventions

Intervention 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.

Sponsors

FAPESP - The State of São Paulo Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. Use of fibrates and/or estatins; 2. Use of nutritional supplementation (vitamins and minerals), metformin and or anticoagulant; 3. Severe AIDS or associated diseases.

Design outcomes

Secondary

MeasureTime frame
1. 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.

Primary

MeasureTime frame
1. 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.

Contacts

Public ContactJ.M. Oliveira-Menegozzo
julicristie@yahoo.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)