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Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children

NCT02248948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2019-07-19

No results posted yet for this study

Summary

This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DIETARY_SUPPLEMENT

Omega-3 Fatty Acids

Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.

DIETARY_SUPPLEMENT

Medium Chain Triglycerides

Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.

Sponsors & Collaborators

  • Clever Instruments S.L.

    collaborator INDUSTRY

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Jordi Sasot Llevadot, MD · Centro Médico Teknon

  • Ana Bielsa, MD · Unidad Clínica Familianova Schola

  • Miquel Sisteré, MD · Centre de Salut Mental Infanto-Juvenil, Lleida

  • Esther Cardo Jalón, MD · Unidad Pediártica Balear, Palma de Mallorca

  • Isabel Hernández Otero, MD · Hospital Universitario Virgen de la Victoria, Málaga.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248948 on ClinicalTrials.gov