A Phase 3 interventional study of DHA Omega-3 and Placebo in Attention Deficit Disorder, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by University of Cincinnati · Phase 3, Interventional, and Treatment
The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.
This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks
Drug: Placebo
Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks
Drug: DHA Omega-3
Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks
Also known as: Docosahexaenoic acid, Omega 3 Fatty Acids
corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
Also known as: Inactive drug
Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)
Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms
Time frame: 10 weeks
| Milestone | Placebo | DHA Omega-3 |
|---|---|---|
| Started | 14 | 16 |
| Completed | 10 | 9 |
| Not completed | 4 | 7 |
Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms
| score on a scale | Placebo | DHA Omega-3 |
|---|---|---|
| Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV) | 47.1 ± 8.5 | 46.1 ± 6.6 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| DHA Omega-3 | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | Placebo | DHA Omega-3 | Total |
|---|---|---|---|
| <=18 years | 14 | 16 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | DHA Omega-3 | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 11 | 12 | 23 |
| Race (NIH/OMB)(Participants) | Placebo | DHA Omega-3 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 7 | 9 | 16 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | DHA Omega-3 | Total |
|---|---|---|---|
| United States | 14 | 16 | 30 |
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Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of Cincinnati