Entrain The study Entrain carried out at the Jérôme Lejeune Institute has just been published (in Feb 2010) in a scientific review entitled POLS ONE*. It aimed at evaluating the effects of folinic acid treatment on neurological functions on 117 children with Down Syndrome aged from 6 to 30 months. The results revealed a positive effect of the treatment on the psychomotor development of some of the children.
Various anomalies in the use of vitamin B (B1, B6…) are well known to have an effect on intellectual performances on patients, carriers or non-carriers of Down syndrome. In patients with Down Syndrome, there is a functional disorders in vitamin B9 which triggers several cellular anomalies. This is due to the fact that 7 genes involved in the use of this vitamin by the cell (metabolism) are situated on the chromosome 21.
The aim of this clinical trial is therefore to give more vitamin B9-actually, folinic acid, a very close derivate- to these patients with Down Syndrome (aged from 6 months to 2 years and a half) in order to evaluate how effective this molecule is in ameliorating these children’s cognitive functioning.
The treatments lasted a year for each patient. Specialized psychometric evaluations are carried out to evaluate intellectual development before the treatment, after six months and after a year. Half the patients are treated with folinic acid and the other half with a product which has exactly the same aspect but without any biological activity (placebo). Folinic acid usually doesn’t have any side effects on patients who are in good health, regardless of whether they have Down Syndrome or not.
The treatments, with the active product or the placebo, were very generously donated by Thérabel-Lucien Pharma laboratories.
117 children were included into the trial and a complete analysis of 87 of the patient’s files was carried out (the others couldn’t be analysed due to technical reasons). Before the treatment, no difference was observed among the patients from the “folinic acid group” and the “placebo group”.
The results of this study are very interesting. They show that folinic acid is probably useful in cognitive development in young patients with Down Syndrome. The development of children treated with folinic acid is increased by about 9% compared with the children receiving placebo.
Actually, the results show that the children whose intellectual development progresses are those who also receive a thyroid hormone (thyroxin). The evolution in the age of development in that group is 18% higher than in the placebo group. This is a bit unexpected but not illogical: it has been known for a long time that thyroid hormones are useful for brain development in babies.
In therapeutic fields one must always be very prudent. However, given the high tolerance to folinic acid, it appears legitimate to give it, under medical control, to babies with Down Syndrome who are taking thyroid hormones, (this concerns 1/3 of patients) including very young ones.
Great clinical studies are more than ever necessary to scientifically validate medication which turns out to be useful in treating patients with Down Syndrome. But carrying out these studies is not easy (psychomotor tests, logistic resources) and is often very expensive. These last studies have enabled researchers to show that the developmental quotient of patients with Down Syndrome can be increased.
The next step will be determining if it can be done on a long run and if it can be done on older patients. We will not fail to keep you informed about the next clinical trials and more importantly, their results.
To all families, thanks again for their participation!