Food Additives Effects on Children With ADHD
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|ClinicalTrials.gov Identifier: NCT03342469|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment|
|Attention Deficit Hyperactivity Disorder||Other: Artificial Food Coloring Other: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants will be exposed to all challenge mixtures with adequate washout periods between exposures.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||The investigators and the participants will be masked as to contents of the chocolate cookies provided during the challenge periods. One research assistant will be unblinded and will not have contact with the participants.|
|Official Title:||Food Additives Effects on Children With ADHD|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: Artificial Food Colorings Challenge
A high consumer child dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday). The chocolate will mask the food coloring.
Other: Artificial Food Coloring
Artificial Food Coloring (AFC)
Other Name: AFC
Placebo Comparator: Placebo Challenge
The participants will consume chocolate cookies with no food coloring.
Chocolate cookies with no additives
- Conners 3-P and 3-T Assessment [ Time Frame: Once a week for 6 weeks ]The Conners Assessment quantifies behavioral symptoms. It yields T-scores of 0-100 for the sub-scales of inattention, hyperactivity/impulsivity, learning problems, executive function, aggression, and peer relations. A score of >63 is indicative of ADHD.
- Electroencephalogram (EEG) [ Time Frame: Once a week for 6 weeks. ]The participants will have small disks placed on their scalp that are connected to electrodes which in turn are connected to a computer. The participants will sit still with their eyes closed while the computer records their brain wave data
- Cognitive Testing [ Time Frame: Once a week for 6 weeks ]The participant will complete computerized cognitive testing designed for ADHD.
- Nutrient and Food Additive Intake [ Time Frame: 6 weeks ]Participants will keep a food log.
- Symptom Diary [ Time Frame: 6 weeks ]Parents of the participant will keep a symptom diary.
- Hemoglobin [ Time Frame: Baseline ]A small finger pricked will be completed to test iron levels in the blood.
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): NCT03342469
|Contact: Anna Kirkland||(202) 885- firstname.lastname@example.org|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Contact: Anna Kirkland 202-885-6099 email@example.com|
|Principal Investigator:||Kathleen Holton, PhD||American University|