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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00011466
Other study ID # NCRR-M01RR00240-1738
Secondary ID
Status Recruiting
Phase N/A
First received February 21, 2001
Last updated June 23, 2005

Study information

Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Specific nutrient deficiencies have been described in children with ADHD including zinc, magnesium, calcium, and essential fatty acids. In addition, children with ADHD have been noted to behave and concentrate better in some studies when the ratio of protein compared with carbohydrate in their diets was increased, however, this was anecdotal information noted from studies designed to study other factors, so its not clear if the increased protein is actually the cause of the improved behavior. In our clinical practice, we have noted a high incidence of what appears to be carbohydrate "craving" among children with ADHD, which can put children at risk for obesity, diabetes type II, and additional dysregulation of mood and concentration. Carbohydrate craving is a well-documented phenomenon in adults, particularly those with certain patterns of obesity, mood disorders, or those undergoing smoking cessation programs. It has not been studied in children, however. Thus, this initial study was designed to determine 1) whether or not children with ADHD have different patterns of nutrient intake compared with children in the same family and children in families without a child with ADHD, 2) if the described nutrient deficiencies are due to decreased intake, and 3) whether there is an increased occurrence of carbohydrate craving, based on parents' perceptions, eating patterns, and actual intake, among children (or certain subgroups of children) with ADHD. The information gained from this study will be used to design additional studies to test causative hypotheses and intervention strategies.


Description:

Three day prospective diet records will be completed on 25 children aged 5-13 with ADHD, their sibling controls, and 25 children from control families without ADHD in order to assess their protein, carbohydrate, fat, calorie, and multiple specific nutrient intakes. In addition, a questionnaire will be completed on each child describing several aspects of eating behavior, food choices, and gastrointestinal, allergic, and infectious concomitants.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 13 Years
Eligibility Children with ADHD (combined or hyperactive-impulsive subtype) by Parent and Teacher Rating Scales, history, and interview who do not have a medical or neurologic problem that influences eating, who are not on medication for ADHD or another medication that may influence eating, aged 5-13 years with a sibling in the same age range meeting the same criteria but without ADHD. This sibling must have a normal Parent Rating Scale and not have been held back in school or been on medication or diagnosed with a learning, developmental, or neuropsychiatric disorder. Controls must meet the same criteria, and may not have a first-degree relative with ADHD. All participants must have a normal intellect, and may not have an autistic spectrum disorder or major depression.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Heppe Foundation

Country where clinical trial is conducted

United States, 

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