Intervention With Omega-3 in Children With Attention Deficit Hyperactivity Disorder(ADHD)

University Hospital of North Norway

Status: Active, not recruiting

Conditions: ADD; ADHD

Treatments: Other: Medical Paraffin; Dietary Supplement: Calanus oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02986672

ADHD_Kvernmo

Details and patient eligibility

About

This study aims to determine if marine monounsaturated and polyunsaturated fatty acids can benefit children aged 6-16 years with ADHD and related symptoms. It is a randomized, double-blind, placebo-controlled study involving approximately 330 children from Norway. The study will assess ADHD symptoms reported by caregivers, teachers, and the child at baseline, after 6 months of treatment, and 6 months post-treatment. Secondary outcomes will include reading and writing difficulties, cognitive functions, and physical health.

Full description

Children with ADHD often exhibit low blood levels of omega-3 fatty acids, which are not correlated with their diet. Low omega-3 levels are associated with poor cognition and behavior. Previous research indicates that omega-3 supplements can enhance literacy, behavior, memory, and reaction time in children with ADHD, although the improvements are generally small to modest.

A study on adolescent mental health in North Norway from 2003-2005 revealed that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).

Key limitations in existing studies include small sample sizes, varying methodologies, short intervention periods, and the absence of control groups. This study addresses these limitations by using whole marine oil from the zooplankton Calanus finmarchicus, which naturally contains stearidonic acid (a precursor to EPA) and astaxanthin, a natural antioxidant.

Previous clinical studies did not utilize pure oil from zooplankton such as Calanus finmarchicus. This oil is not chemically processed, retaining its natural antioxidants.

Blood tests will be conducted before and after the 6-month intervention period to measure the omega-3 index and include general hematology and biochemistry.

Enrollment: 330 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ADHD according to DSM-IV criteria

Exclusion criteria

• IQ below 70
• infantil autism, psychosis, bipolar disorders and serious somatic disease
• any abnormal or pathological blood test during trial
• ADHD medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 2 patient groups, including a placebo group

Calanus oil

Active Comparator group

Description:

Children receiving omega-3 in form om calanus oil in capsule form

Treatment:

Dietary Supplement: Calanus oil

Placebo

Placebo Comparator group

Description:

Children receiving medical paraffin in capsule form (2 ml volume per day)

Treatment:

Other: Medical Paraffin