Since 1995 I have been fighting to get a re-appraisal of medical research issues in Down syndrome and fighting to get new research underway. In 1996 I collected research information together and talked to medical experts in genetics, in biochemistry and in nutrition.  

Two independent teams did a systematic review of evidence from published research projects from the past 20 years. The result of these reviews was to largely discredit the old research and to highlight the need for a high quality research project. 

In-Vitro & In-Vivo evidence

During the three years it took to get this review of research completed there was additional information from new research projects being published.  The evidence from several in-vitro studies indicated that the speculation of progressive injury to the brain in patients with Down syndrome was probably correct.  

In-vitro experiments use live cells from patients who have Trisomy 21, sometimes these cells are blood cells from patients of various ages.  But with the very great number of abortions these days there has be experiments using live cells taken from abortion babies. (I offer no comment on the ethics of abortion I only state the facts.)

Live cells will survive in a culture medium for several days and this allows experimenters to test their survival in a lab environment.  Data obtained will not always translate to in-vivo (In lifelike) conditions because we function not only at a cellular level but also as very complex organisms.  We have organs that will remove toxins from the blood stream and maintain the correct levels of nutrients in every part of our body this includes the brain.   The blood stream is the transport system. 

An example of this inability to translate in-vitro studies to in-vivo applications is the confusion over in-vitro findings where Vitamin C was seen to have a pro-oxidative effect which is intuitively not what we might expect from a vitamin that is an antioxidant.  However in-vivo (in real life)  high levels of vitamin C in the blood stream are not likely to happen because any excess vitamin C is detected, it is removed, and is then excreted.   This is why it is advisable to only use time release Vit C so this vitamin is released slowly over several hours at a very low dose rate that gives more benefit.

So although the evidence from in-vitro studies indicates a potential benefit from the use of antioxidants we still need to conduct in-vivo studies to determine if are any real life  benefits. 

An antioxidant Research Project (Update : Study has concluded in 2006 and results are awaited.)

The review of research by the Institute of Child Health did produce good (in-vitro) evidence that elevated oxidative stress and folic acid deficiency might be causing many of the health and development problems in Down syndrome.  A therapy was proposed and a protocol document prepared for a high quality clinical trial of a new antioxidant therapy. This would be a placebo controlled, randomized, double blind trial which is the gold standard for evidence based medicine..  

The Down Syndrome Research Foundation provided the initial £2000 in funding for the preliminary work to do the review of research and draw up this protocol document.  We also provided £35,000 as the initial funding to get the research project underway.  The total cost of the project is £400,000 so we needed additional support to fund this project.

The Down's Syndrome Association

 The Downs Syndrome Association has agreed to support this project.  They have  signed the contract to fund this project.  That money will be raised over the next three years.  All DSA branches need to raise money to help fund this project and set aside some of their surplus funds for this project. Donations can be restricted to the ICH project. 

This is the biggest Down's syndrome research  project ever conducted. There has never been a project this big or with such a good scientific basis for a successful outcome. Every parent of a child with Down syndrome should support this project.

Foundation Jerome Lejeune

The discoverer of the cause of Down syndrome is Professor Jerome Lejeune and this foundation carries on his work.  They asked if they could collaborate with our project and an agreement was reached. This foundation made a contribution of £90,000 to cover the additional costs of their participation and collaboration. In  Paris there will be in a separate study but using a very similar protocol and babies of the same age.  This will increase the amount of information and quality of the research. 

The Institute of Child Health

The Institute of Child Health is in charge of this project.  Volunteers will be needed.  The Institute of Child Health has warned against unreasonable expectations by parents.  The project will test a therapy that may help, but the basis for the study is evidence from in-vitro studies and this evidence may not translate to in-vivo evidence.  We are supporting this research project to find that in-vivo evidence.   

Will this therapy work?  Who is on the Placebo? 

We would not fund this research project if we were not hopeful of a good outcome. We want parents learn about the project and consider taking part in the project.   Some babies will be on a placebo (25%). no one can know who is on the placebo or the trial is invalid.  Being on the placebo does not infer a loss of benefit from the study.  If a benefit is detected early, then all the babies will be given the therapy that is seen to be the most effective. This is part of the ethical considerations. 

Babies must have Down's syndrome and must be under age 6 months.  The study will last 18 months for each participant. There are two centers one in London and one in Birmingham. 

Parents who want to participate please send me an email,  dsrf@dsrf.co.uk
You can ask The  Institute of Child Health for an information pack on the Down's Syndrome Antioxidant project.  

We provide information for parents because parents need to know about this research.

The Institute of Child Health has not authorized any of the information on our website. 

FINDING 200 BABIES UNDER AGE 6 MONTHS IS VERY DIFFICULT.

PLEASE TELL NEW PARENTS ABOUT THIS PROJECT.