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

Phase 2

• Conditions: Anorexia Nervosa
• Interventions: Dietary Supplement: fatty acids preparation- eye-q

• Registration Number: NCT01761942
• Lead Sponsor: Institute of Psychiatry and Neurology, Warsaw

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline	day 70th	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)

Secondary Outcome Measures

Name	Time	Method
reducing EAT -26	day 70th	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
changes in CGI	day 70th	to compare the effects of fatty acids with the effect of placebo by change from baseline to day 70 in CGI (Clinical Global Impression)
change in HDRS	day 70 th	to compare the effects of fatty acids with the effect of placebo on change form baseline to day 70 in Hamilton Depression Rating Scale
changes in BDI	day 70th	to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 in Beck Depression Inventory
changes in YBOCS	day 70th	to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 Yale-Brown Obsessive-Compulsive Scale
adverse events	70 days time	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
clinical laboratory tests	day 70 th	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)

Trial Locations

Locations (1)

Institute of Psychiatry and Neurology,; 🇵🇱 Warsaw, Mazowieckie, Poland