To draw definite conclusions about the effectiveness of omega-3 PUFA supplementation in anorexia nervosa patients a double-blinded, placebo-controlled randomized controlled trial (RCT) with a substantial sample size should be conducted. Prior to…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters are inclusion rate, treatment adherence, and dropout rate.
Secondary outcome
A complete overview of the assessments is provided in Table 1 of the C1
research protocol. In addition to assessments that are completed as part of
care as usual, we will monitor side effects at two time points. Furthermore,
participants and one of their parents or legal guardians will be asked to
complete two internationally validated assessment instruments at two time
points (baseline and 8 weeks), namely:
* the Dutch version of the Children*s Depression Inventory 2nd edition (CDI-2)
(61), to assess depressive symptoms. The CDI-2 has adequate psychometric
properties and has been validated in 8-21-year-old children and adolescents.
* and the Dutch version of the Screen for Child Anxiety Related Emotional
Disorders (SCARED-NL) (62), to assess anxiety symptoms. The SCARED-NL has
adequate psychometric properties and has been validated in 7-19-year-old
children and adolescents.
Background summary
Anorexia nervosa (AN) is an eating disorder characterized by a morbid fear of
weight gain, which results in chronic dietary restriction and weight loss
behaviors. AN is associated with severe medical morbidity, decreased quality of
life, defects in cognitive and emotional functioning, and significant
mortality. Furthermore, most patients with AN have at least one comorbid
psychiatric diagnosis. Depressive and anxiety disorders are the most common
co-occurring disorders. Such comorbidity has repeatedly been associated with
adverse outcomes and is known to complicate treatment. Though sufficient
caloric intake reduces depressive and anxiety problems in patients with AN, it
does not sufficiently eliminate symptoms. Apart from a deficiency of nutrients
and caloric intake, patients with AN have significant deficiencies in dietary
intake of omega-3 polyunsaturated fatty acids (PUFAs) such as eicosapentaenoic
acid (EPA) and docosahexaenoic acid (DHA). Omega-3 PUFAs are essential fatty
acids and are found in foods which are strictly avoided by patients with AN,
also when caloric intake is restored. The deficiency of omega-3 PUFAs in AN may
be involved in the etiology of the comorbid depressive and anxiety problems and
deficits in cognitive functioning. Multiple meta-analyses have demonstrated
positive effects of omega-3 PUFA supplementation on several psychiatric
disorders, including depressive and anxiety disorders. Moreover, omega-3 PUFAs
positively affect brain development. Considering the above, we hypothesize that
the supplementation of omega-3 PUFAs will improve comorbid depression, anxiety,
and cognitive functioning in patients with AN, subsequently improving treatment
outcomes. Studies examining this hypothesis are very scarce and have
methodological limitations.
Study objective
To draw definite conclusions about the effectiveness of omega-3 PUFA
supplementation in anorexia nervosa patients a double-blinded,
placebo-controlled randomized controlled trial (RCT) with a substantial sample
size should be conducted. Prior to conducting such an RCT, it is important to
examine the feasibility of the study, which is the aim of the current pilot
study. More specifically, through this study we will (1) examine how many
patients with AN are willing and able to use omega-3 PUFA supplements and to
complete participation, (2) assess side effects experienced by participants,
and (3) test the assessment instruments that will be used in a future RCT.
Study design
The current study is a one group pilot/feasibility study.
Intervention
All participants will receive 3 capsules of 764 mg EPA and 236 mg DHA daily for
a period of 8 weeks.
Study burden and risks
The main benefit of participation in this feasibility study is that
supplementation of omega-3 PUFAs increases AN patients* omega-3 PUFA intake.
Omega-3 PUFAs are essential fatty acids and should be included in a healthy
diet, but foods rich in omega-3 PUFAs are generally strictly avoided by AN
patients. Omega-3 PUFA intake may also have a positive effect on symptoms of
depression and anxiety.
The risks associated with the current study are negligible and the burden is
minimal. Participants may experience mild side effects. Participants and their
parents will be asked to complete 2 questionnaires at 2 time points (baseline
and end of study). It will take approximately 10 minutes to complete each
questionnaire (i.e., in total 2x20=40 minutes per person). Participants will
also be asked to complete a side effects questionnaire at 2 time points, which
will take 5 minutes per assessment moment (i.e., in total 2x5=10 minutes).
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* 10- to 19-years old (inclusive);
* diagnosed with anorexia nervosa;
* currently receiving inpatient or day treatment at De Bascule.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* mental incapacity;
* intellectual impairment as estimated or determined by a mental health
professional (intelligence quotient of <80);
* chronic psychosis or schizophrenia;
* insufficient mastery of the Dutch language by the adolescent and/or parents;
* substance dependence requiring detoxification;
* inability to take pills;
* current use of omega-3 supplements;
* known allergy of omega-3 supplement ingredients.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71760.018.19 |
| OMON | NL-OMON23442 |