Omega 3 in LES and APS

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01956188
• Date of registration: 25/09/2013
• Prospective Registration: Yes
• Primary sponsor: University of Sao Paulo
• Public title: Omega 3 in LES and APS
• Scientific title: Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
• Date of first enrolment: May 2014
• Target sample size: 22
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01956188
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Brazil

Key inclusion & exclusion criteria

Inclusion Criteria:

• Age between 7 and 40 years

Exclusion Criteria:

- Cardiovascular dysfunction

- Rhythm and conduction disorders

- Musculoskeletal disturbances

- Kidney and pulmonary involvements

- Peripheral neuropathy

- Use of tobacco

- Treatment with lipid-lowering or hypoglycemic drugs

- Fibromyalgia

- Use of chronotropic or antihypertensive drugs

- Physically active subjects



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Primary Antiphospholipid Syndrome

Systemic Lupus Erythematosus

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: EPA and DHA supplementation

Primary Outcome(s)

Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y) [Time Frame: 4 months]

Endothelial function [Time Frame: 4 months]

Secondary Outcome(s)

Clical features [Time Frame: 4 months]

Clinical features [Time Frame: 4 months]

Secondary ID(s)

Omega 3 and SLE and APS USP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors