This fully blinded trial studied 93 children aged 7 to 12 with ADHD in Canterbury, New Zealand, who were not taking ADHD medication. Most (83%) also had another condition. By chance, 47 got a vitamin and mineral formula called Daily Essential Nutrients and 46 got a placebo, for 10 weeks.
Clinicians rated the children on the formula as more improved overall than those on placebo. The difference was moderate. Clinicians also rated the formula group better on inattention, though parent and teacher ratings of attention showed no clear difference. The formula group did better on emotional control and aggression. Teachers saw better emotional control, and parents reported fewer conduct problems. Of the formula group, 47% were rated much or very much improved, against 28% on placebo, but this gap could have been chance.
The formula did not beat placebo on hyperactive and impulsive symptoms. Clinician, parent and teacher ratings of ADHD symptoms overall showed no clear difference. Two children dropped out of each group, and side effects did not differ.
This single-center trial may have been too small to pick up subtle changes, and it did not adjust for running many comparisons. Most effects were small to medium. The authors call the results encouraging but preliminary, needing repeat studies.
The authors suggest the formula may be a favorable option for some children, especially those with both ADHD and emotional dysregulation, while noting its direct benefit for core ADHD symptoms was modest.
Talk to a clinician about your own or your child's situation.
The numbers Stats and what the terms mean
The statistics behind the plain-language claims above.
- Rucklidge, 2017: clinician rating of overall improvement across all areas of functioning (CGI-I-Overall), p = .029, ES = 0.46.
- Rucklidge, 2017: clinician rating of ADHD symptoms (ADHD-RS-IV), p = .415, ES = 0.17.
- Rucklidge, 2017: parent rating of ADHD symptoms (CPRS-R:L), p = .540, ES = 0.13.
- Rucklidge, 2017: teacher ratings of ADHD symptoms, ES ranged from 0.03 to 0.13.
- Rucklidge, 2017: children rated "much" to "very much" improved overall, 22 (47%) versus 13 (28%), p = .065; OR = 2.2; 95% CI: 0.9 to 5.3.
- Rucklidge, 2017: the same measure among children who completed the trial as planned (per-protocol), 20 (51%) versus 11 (27%), p = .03; OR = 2.9; 95% CI: 1.1 to 7.3.
- Rucklidge, 2017: a 30% drop in inattentive symptoms (post hoc), 15 (32%) versus 4 (9%), p = .005; OR = 4.9; 95% CI: 1.5 to 16.3.
- Rucklidge, 2017: a 30% drop in hyperactive and impulsive symptoms, p = .951; OR = 1.0; 95% CI: 0.4 to 2.5.
- Rucklidge, 2017: parent-rated conduct problems (SDQ-Parent), ES = 0.52.
- Rucklidge, 2017: teacher-rated emotional control (BRIEF-Teacher), ES = 0.66.
- Rucklidge, 2017: clinician ratings of general functioning, ADHD and mood (C-GAS, CGI-I-ADHD, CGI-I-Mood), ES ranged 0.48 to 0.53.
- Rucklidge, 2017: trends that were not significant, parent-rated dysregulated mood (CMRS-P) ES = 0.35, teacher-rated conduct problems (SDQ-Teacher) ES = 0.48, and problem behaviors rated by parents (SDQ-parent) ES = 0.41 and teachers (SDQ-teacher) ES = 0.45.
What the terms mean:
- P-value A number from a statistical test that shows how unusual a result would be if there were really no effect; here it compares the formula group with the placebo group.
- Effect size (ES) A number that shows how big a difference is, separate from whether it was statistically significant; here it is the gap between the formula and placebo groups.
- Statistical significance A label for a result whose p-value falls below a cutoff set in advance, most often 0.05; it is a statistical term, not the everyday sense of important.
- Odds ratio (OR) How much more likely one group was to reach an outcome than the other; 1.0 means no difference between groups.
- Confidence interval (95% CI) A range of values around the result that fit the data reasonably well; a range that includes 1.0 for an odds ratio means no difference is still plausible.
- Per-protocol An analysis that counts only the children who completed the trial as planned.
- Post hoc An analysis the researchers chose after seeing the data, rather than planning it in advance.
Source: Julia J. Rucklidge, Matthew Eggleston, Jeanette M. Johnstone, et al.. Vitamin‐mineral treatment improves aggression and emotional regulation in children with ADHD : a fully blinded, randomized, placebo‐controlled trial. Journal of Child Psychology and Psychiatry (2017). doi:10.1111/jcpp.12817