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Trial record 69 of 978 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT02986672
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:
This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty acids on children aged from 6-13 years, with ADHD/ADD and related symptoms. The study is a randomized, double-blind placebo-control study including approximately 330 children from Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months post treatment). The secondary outcome measures are reading and writing disabilities, cognitive functions, and physical Health.

Condition or disease Intervention/treatment Phase
ADHD ADD Dietary Supplement: Calanus oil Other: Medical Paraffin Not Applicable

Detailed Description:

Children with ADHD are shown to have low blood levels of omega-3 fatty acids, not related to diet. Low levels of omega-3 has also been directly related to poor cognition and behavior. Trials have shown that supplement with omega-3 may improve literacy and behavior in children with ADHD symptoms. It has also been shown to improve both memory and reaction time. The effect sizes found in meta analysis of placebo- controlled clinical trials on ADHD core symptoms are small to modest. In a study of adolescent mental health in North Norway in 2003-2005 a significant association was found between intake of fish and hyperactivity as adolescents with a high intake showed less hyperactivity than peers with a low intake (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).

There are several key limitations to the existing studies. Underpowered sample size, different methodology and short intervention periods are some factors raising the question of effect size. Other trials have no control group. We are designing this study taking these limitations into consideration. In addition we are using whole marine oil from the zooplankton Calanus finnmarchicus that has a high natural content of steardidonic acid 18:3 n-3 that is a precursor to EPA. The oil also has a high content of astaxanthines - a natural antioxidant.

Earlier clinical studies have not used pure oil from zooplankton such as Calanus finnmarchicus. The oil is not processed chemically such as ethylation, that not only alter the structure of the oil, but also devoids the product of its natural antioxidants.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ADHD and Nutrition: The Influence of Omega-3 on ADHD Related Symptoms
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Calanus oil
Children receiving omega-3 in form om calanus oil in capsule form
Dietary Supplement: Calanus oil
Omega-3 oil in form of calanus oil

Placebo Comparator: Placebo
Children receiving medical paraffin in capsule form (2 ml volume per day)
Other: Medical Paraffin
2ml per day




Primary Outcome Measures :
  1. ADHD rating scale by Russel Barkley [ Time Frame: 6 months ]
    Reduction in symptom score


Secondary Outcome Measures :
  1. BRIEF - Behavior Rating Inventory of Executive Function [ Time Frame: 6 months ]
    Reduction in symptom score

  2. WISC - Wechsler Intelligence Scale for Children [ Time Frame: 6 months ]
    Change

  3. CELF - Clinical Evaluation of Language Fundamentals [ Time Frame: 6 months ]
    Change

  4. ARI - Affective Reactivity Index - a scale that contains six symptom items and one impairment item about irritability [ Time Frame: 6 months ]
    Reduction in symptoms

  5. CPT - Continuous Performance test - a task-oriented computerized assessment of attention-related problems in individuals aged 8 years and older [ Time Frame: 6 months ]
    Change



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- ADHD or ADD 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
  • Omega-3 supplement taken until 3 months before inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986672


Contacts
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Contact: Judeson R Joseph, MD +4777755705 judeson.joseph@unn.no
Contact: Siv E Kvernmo, MD PhD +4777755726 siv.kvernmo@uit.no

Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Troms, Norway, 9038
Contact: Judeson R Joseph, MD    77755705    judeson.joseph@unn.no   
Contact: Siv Kvernmo, Prof MD    77755725    siv.kvernmo@uit.no   
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Study Director: Siv Kvernmo, MD PhD University of Tromso

Publications:

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02986672     History of Changes
Other Study ID Numbers: ADHD_Kvernmo
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital of North Norway:
ADHD
omega 3
children
nutrition
MUFA
ADD
PUFA
Calanus
learning difficulties

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders