Final thread for today micronutrient supplementation as a treatment for ADHD. This thread will be discussing the use of high dose multivitamin, mineral, amino acid, and antioxidant supplement formulation. There are two studies, one completed and one in process. Buckle up. #ISNPR
The large multinational 3 university study got IRB approval from all three centers plus FDA and Canadian ethics board approval. I believe they are using in part the Empower supplement whose makers were disciplined for false claims about their product.
The research/researchers do not get funding from the makers of EmpowerPlus, they use other grants, but the company does supply their product and matching placebo product for the research for free. (This is a fairly standard model for university research) #ISNPR2019
(The ADHD researchers didn’t mention or plug the name EmpowerPlus I just happen to know what they have mostly used and needed to clear the air about the company and their research)
Let’s start with @JuliaRucklidge study of 93 med free kids with ADHD. They were either med naive or subject to a 4 week washout. Avg age 9.7 yrs, 76% male. 28% had inattentive type, 67% combined type. 83% had other comorbid disorders (mood/anxiety/conduct). #ISNPR2019
In general these were *treatment resistant* kids with lots of comorbid problems. There was a 10 week RCT of micronutrients vs placebo. #isnpr2019
Here are the results. What you see is hyperactivity does not improve, but inattentiveness, general functioning, mood and anxiety improves. 
Some signals of improvement were there for several other issues (irritability, aggression) but power wasn’t high enough, so they are repeating the experiment with double the number. This is the MADDY study. #ISNPR2019
Here is the micronutrient intervention. Many of these are above the RDA but all are below the Upper Limit for daily safe intake. #ISNPR2019
Main downside: need to take several pills three times a day. The number and frequency of pills was the most common reason given for discontinuing the treatment. #ISNPR2019
Dr. @JuliaRucklidge followed the 93 kids for 1 year after open label part...after initial study they were free to continue the supplement, go to meds, or do nothing. 20% continued micronutrients, 20% went to meds, the rest did nothing or bounced from one to the other.
Here are some results: note the small numbers
Some bits about the initial study...they now have 9 year follow ups for a few of the kids and there haven’t been adverse events from the high dose supplementation. Things like neuropathy from high B6 are being monitored and have not been found. #isnpr2019
Some biomarkers were measured...things like serum levels of nutrients and MTHFR status had no impact on response. Main risk would be unmasking hemochromatosis or Wilson’s disease (both rare and not been found).
Secondly, there was no difference in demographics of the kids who in the longer term follow up stayed on the micronutrients vs stopping treatment or going to meds *except* those who stayed were *more* likely to have been treated with medications in the past.
Now to the larger MADDY study in progress...they are collecting hair, spit, blood, urine, and stool to measure various biomarkers. There are no healthy controls everyone enrolled is ill, and many are treatment resistant. They all have ADHD *plus* irritability/aggression.
(Or mood dysregulatuon)
Preliminary results are promising so far with some very good responders, but need to enroll 10 more patients to get a proper amount of data.
Here’s a look at historical dietary/supplement treatments for ADHD. Size of box indicates # of studies, light gray means removal from diet, dark gray means adding to diet. #ISNPR2019
So...to be continued! #MADDY #ISNpR2019
Lewis Mehi-Madrona MD PhD is a family practice doctor who runs an academic family medicine program in Maine. Doing a trial of the EmpowerPlus and EPA for bipolar disorder. He says psychiatrists won’t refer to his trial, he gets most referrals from family practice docs.
It has IRB approval and subjects have access to psychotherapy and other treatment as usual. He needs to gather more data to make any conclusions. #ISNPR2019
Just one clarification: Daily Essential Nutrients is the product used in the MADDY trial, it was formulated by the same person as EmpowerPlus but the companies split. 😃
EmpowerPlus is used in the bipolar trial.
