Dietary Intake and Nutrient Status of Children With ADHD | NCT00434928

Studies
Dietary Intake and Nutrient Status of Children With ADHD

NCT00434928

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Feb 14, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
W05-0185

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jan 2007

First Submitted Date

Feb 13, 2007

First Submission Date that Met QC Criteria

Feb 13, 2007

First Posted Date

Feb 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2007

Last Update Posted Date

Feb 14, 2007Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Description Module

Brief 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.

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of ADHD
Age 6-12 years inclusive

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margaret D. Weiss, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Provincial ADHD Program, BC Children's Hospital		Vancouver	British Columbia		Canada

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided