Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa (FASAN)

Institute of Psychiatry and Neurology, Warsaw

Status and phase: Unknown; Phase 2

Conditions: Anorexia Nervosa

Treatments: Dietary Supplement: fatty acids preparation- eye-q

Study type: Interventional

Funder types: Other

Identifiers

NCT01761942

22/2011 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.

Full description

10-week, randomized, placebo-controlled, parallel-group study to compare the efficacy and safety of omega-3 fatty acids with placebo in the treatment of anorexia nervosa. Patients will be randomly assigned to blinded study treatment. Double-blind treatment will be preceded by a medication washout period of 1-28 days if necessary. Some patients may be taking anti-depressants or anti-psychotics, e.g. fluoxetine, prior to admission to the study. In such case the wash out period will depend on the medical treatment (dependent on the drug given) given prior to qualification to the study. Patient will be treated as inpatients during 10 weeks of the study. The study will recruit female inpatients with anorexia nervosa (aged 12 to 19 years), with DSM-IV and ICD-10 diagnosis of anorexia nervosa.BMI below 5 percentile and EAT-26 score > 30 is required at both screening and randomization.

Enrollment: 60 estimated patients

Sex: Female

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anorexia nervosa (DSM IV,ICD-10)
• Female
• Age 12-19
• Written informed consent given by patient and his parents

Exclusion criteria

• Lack of informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

placebo ,anorexia nervosa

Placebo Comparator group

Description:

2x3 placebo capsules with olive oil

fatty acids preparation- eye-q

Experimental group

Description:

2 x 3 tablets of eye -q preparation daily ( 558 mg of EPA, 175 mg of DHA, 60 mg fo GLA).

Treatment:

Dietary Supplement: fatty acids preparation- eye-q