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

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

Detailed Description
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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.

Official Title
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A 10-week Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Omega-3 Fatty Acids Oral Capsules Compared With Placebo in the Treatment of Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Dietary Supplement: fatty acids preparation- eye-q


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo ,anorexia nervosa<br>2x3 placebo capsules with olive oil | |
| Experimental: fatty acids preparation- eye-q<br>2 x 3 tablets of eye -q preparation daily ( 558 mg of EPA, 175 mg of DHA, 60 mg fo GLA). | Dietary Supplement: fatty acids preparation- eye-q<br>* 3x2 tablets daily by 70 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline | The primary objective of this study is to compare the efficacy of EPA fatty acids with that of placebo as add-on treatment for inpatients with anorexia nervosa, as assessed by the change from baseline to day 70 in BMI (body mass index) | day 70th | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducing EAT -26 | 1. To compare the effects of omega-3/6 fatty acids with the effect of placebo in reducing EAT-26 (Eating Attitude Test-26) total score at day 70 compared with baseline | day 70th | 
| changes in CGI | to compare the effects of fatty acids with the effect of placebo by change from baseline to day 70 in CGI (Clinical Global Impression) | day 70th | 
| change in HDRS | to compare the effects of fatty acids with the effect of placebo on change form baseline to day 70 in Hamilton Depression Rating Scale | day 70 th | 
| changes in BDI | to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 in Beck Depression Inventory | day 70th | 
| changes in YBOCS | to compare the effects of fatty acids with the effect of placebo by changes in Yale-Brown Obsessive-Compulsive Scale | day 70 th | 
| changes in YBOCS | to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 Yale-Brown Obsessive-Compulsive Scale | day 70th | 
| adverse events | to evaluate the safety and tolerability of omega-3 fatty acids compared with placebo in the treatment of anorexia nervosa, as assessed by incidence and nature of adverse events | 70 days time | 
| clinical laboratory tests | to evaluate the safety and tolerability of omega-3 fatty acids compared with placebo in the treatment of anorexia nervosa, as assessed by changes from baseline to day 70 in clinical laboratory tests (lipids metabolism - triglycerides, HDL and LDL cholesterol) | day 70 th | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3 fatty acids, anorexia nervosa, efficacy, safety