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

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

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

Study Overview

• Status: Unknown
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Dietary supplement: fatty acids preparation- eye-q

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Agnieszka Piróg-Balcerzak, MD; Phone Number: 48606431574; Email: askapb@wp.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-957
      • Recruiting
      • Institute of Psychiatry and Neurology,
      • Contact: Agnieszka Piróg-Balcerzak, MD; Phone Number: 48-606-43-15-74; Email: askapb@wp.pl
      • Principal Investigator: Agnieszka Piróg-Balcerzak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo ,anorexia nervosa; 2x3 placebo capsules with olive oil
Experimental: 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).	Dietary supplement: fatty acids preparation- eye-q; 3x2 tablets daily by 70 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Psychiatry and Neurology, Warsaw
• Investigators: Principal Investigator: Agnieszka Piróg-Balcerzak, MD, Institute of Psychiatry and Neurology, Warsaw

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 7, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: safety; efficacy; anorexia nervosa; omega-3 fatty acids
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 22/2011 (Other Identifier: Institute of Psychiatry and Neurology Warsaw)