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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00434928
Other study ID # H05-70464
Secondary ID W05-0185
Status Completed
Phase N/A
First received February 13, 2007
Last updated February 13, 2007
Start date January 2006
Est. completion date January 2007

Study information

Verified date February 2007
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

Assess the dietary intake of children aged 6-12 years by means of a 24-hour recall and 3-day food record and asses the nutrient status of Vitamin B6, serum ferritin, serum zinc and serum copper of the same children by means of standard laboratory assessments.


Description:

- To document the use of vitamin and vitamin-mineral supplements

- To determine the percent consumption of low nutrient density (LND) foods

- To compare the dietary intake of ADHD children with the established standards of the Dietary Reference Intakes (DRIs)

- To compare the dietary intake of children with ADHD to the dietary recommendations of Canada’s Food Guide for Healthy Eating

- To determine whether dietary intake is moderated by drug treatment

- To assess the pyridoxal-5’-phosphate (PLP), serum ferritin, serum zinc, and serum copper status of ADHD by standard laboratory blood test

- to measure height and weight in ADHD children


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- Primary diagnosis of ADHD

- Age 6-12 years inclusive

Exclusion Criteria:

- No use of medication that affects dietary intake (eg. Risperdal)

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Locations

Country Name City State
Canada Provincial ADHD Program, BC Children's Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

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