NCT01933243

Brief Summary

Adolescents with anorexia nervosa frequently have associated anxiety, and standard medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week trial examining the safety, tolerability, and effectiveness of fish oil nutritional supplements for anxiety in adolescents with anorexia nervosa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 anxiety

Timeline
Completed

Started Aug 2013

Typical duration for phase_2 anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed
Last Updated

April 23, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

August 9, 2013

Results QC Date

October 11, 2017

Last Update Submit

March 23, 2018

Conditions

AnxietyAnorexia Nervosa

Keywords

AnxietyAnorexia nervosaAdolescentsFish oil

Outcome Measures

Primary Outcomes (1)

  • Medication Side Effects Score

    At 6 and 12 weeks, medication tolerability was assessed via self-report of nine potential side effects (e.g. diarrhea, burping). Participants were asked whether they experienced these side effects "never, rarely, occasionally, frequently, or very frequently." Individual responses were assigned a numeric equivalent from 0 to 4, and summed for a total side effect score ranging from 0 to 36. Higher scores indicated greater frequency of side effects and lower medication tolerability.

    6 and12 weeks

Secondary Outcomes (1)

  • Beck Anxiety Inventory-Trait (BAIT)

    Baseline, 6 weeks, and 12 weeks

Other Outcomes (1)

  • Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use

    Baseline, 6 weeks, and 12 weeks

Study Arms (2)

Fish oil

EXPERIMENTAL

Fish oil for 12 weeks

Drug: Fish oil

Placebo pill

PLACEBO COMPARATOR

Placebo pills for 12 weeks

Drug: Placebo pill

Interventions

Fish oilDRUG

Participants will take 4 capsules daily

Also known as: ProEPA Xtra soft gel capsules, Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)
Fish oil
Placebo pillDRUG

Participants will take 4 capsules daily

Also known as: soybean oil placebo capsules
Placebo pill

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization Program

You may not qualify if:

  • Inability to take pills
  • Co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel disease, cancer, cystic fibrosis)
  • Co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar disorder, substance abuse)
  • Currently taking fish oil supplements
  • Inability to participate in study for 12 consecutive weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Anxiety DisordersAnorexia Nervosa

Interventions

Fish OilsEicosapentaenoic AcidDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Mental DisordersFeeding and Eating Disorders

Intervention Hierarchy (Ancestors)

OilsLipidsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsEicosanoidsFatty Acids, UnsaturatedFatty Acids

Limitations and Caveats

Study limitations include small sample size and reliance on self-reported medication adherence.

Results Point of Contact

Title
Andrea Bonny
Organization
Nationwide Children's Hospital
andrea.bonny@nationwidechildrens.org
614-722-2458

Study Officials

  • Andrea Bonny, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2013

First Posted

September 2, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 23, 2018

Results First Posted

April 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)