EXETER, England, Feb. 22 — Children with Down’s syndrome did not improve their Action Points
Explain to interested patients that early vitamin supplementation for children with Down’s syndrome may not improve development.
Note that antioxidant supplements and folinic acid cannot be recommended for children with Down’s syndrome based on the available evidence.
development with the use of antioxidant vitamins, researchers here found.
Psychomotor and language development scores were no better among British children with Down’s given antioxidants or folinic acid (an active metabolite of folic acid) or both than among those who received neither, reported Stuart Logan, MBChB, of Peninsula Medical School, and colleagues online in BMJ.
Nor were biochemical measures of oxidative stress improved by the supplements in the randomized controlled trial.
Vitamin and mineral supplements marketed as holding substantial benefits for children with Down’s are commonly used in the United States and Europe.
However, “parents who choose to give supplements to their children need to weigh their hope of unproved benefits against potential adverse effects from high dose, prolonged supplementation,” the researchers wrote.
The lack of benefit from postnatal supplementation may not be surprising because Down’s screening identifies differences between fetuses with and without trisomy 21 as early as 10 weeks’ gestation, commented Tim Reynolds, M.D., of Queen’s Hospital in Burton-on-Trent, England, in an accompanying editorial.
“Until evidence of any benefit of expensive vitamin supplements is available, they cannot be recommended,” he said.
Developmental delay in Down’s has been thought to result from oxidative neuronal damage, abnormal folate metabolism, or both, they said. The evidence, though, for nutritional interventions to counteract these effects has been poor, particularly in younger children, who had been thought to be most likely to benefit.
So the researchers undertook a well-designed study among 156 infants younger than seven months with Down’s but no severe cardiac defects or other serious long-term illness.
They randomized the children to a daily oral dose of antioxidants (selenium 10 μg, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg) or folinic acid (0.1 mg) or both, or placebo.
All were given as a powder to be mixed with food or drink and were increased in dose by 30% after a child’s first birthday.
After 18 months of follow-up, overall developmental scores as measured on the Griffiths mental developmental scales were similar between children given antioxidants and those who were not (mean 57.3 versus 56.1; adjusted mean difference 1.2 points, 95% confidence interval −2.2 to 4.6).
Likewise, developmental scores were similar for children randomized to folinic acid supplements or not (mean 57.6 versus 55.9; adjusted mean difference 1.7, 95% CI −1.7 to 5.1).
For language development after 18 months of follow-up, the number of words said or signed was similar for children given antioxidants versus none (ratio of means 0.85, 95% CI 0.6 to 1.2) and for those given folinic acid versus none (ratio of means 1.24, 95% CI 0.87 to 1.77).
Nor was there any difference in the age at which infants reached milestones in motor development.
Age at sitting without support was not significantly improved with antioxidants (hazard ratio 1.10, 95% confidence interval 0.77 to 1.56) or folinic acid (HR 1.25, 95% CI 0.88 to 1.78).
Standing did not start significantly earlier with antioxidants (HR 1.25, 95% CI 0.88 to 1.78) or folinic acid (HR 1.14, 95% CI 0.76 to 1.71).
To see whether the supplements could be having a subclinical effect, the researchers looked at biomarkers of oxidative stress in blood samples obtained blood at age one and urine samples.
Activity of antioxidant enzymes — red cell superoxide dismutase and red cell glutathione peroxidase — was not detectably different between treatment groups. Urinary isoprostane concentrations, a marker of lipid perioxidation, were also similar across groups, “indicating that supplementation did not affect oxidative stress.”
The only short-term side effect in the study was an increase in vomiting among infants taking antioxidants (P=0.002), “but the side effects of higher dose preparations used over a long period are unknown.”
Doses used in the study were at least 100% of the recommended daily allowance for all the vitamins and folinic acid, but still were relatively low compared with commercially available preparations, they noted.
“We were reluctant to use higher doses, as data on the safety of high doses for young children are lacking and high dose vitamin C may in fact exhibit pro-oxidant properties,” Dr. Logan and colleagues wrote.
The study was funded by the Down’s Syndrome Association, Fondation Jérôme Lejeune, Down Syndrome Research Foundation, and Szeben Peto Foundation. The work was done at GOSH/UCL Institute of Child Health, which received partial funding from the Department of Health’s NIHR Biomedical Research Centers funding scheme.
Dr. Reynolds reported having been paid to speak at conferences on screening for Down’s syndrome and receiving consulting fees from several manufacturers of analytical reagents.
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I wanted to write and share some more information about the study which is mentioned above. The study’s name is, “Supplementation with antioxidants and folinic acid for children with Down’s syndrome: randomised controlled trial.”
The study claims that supplementation with antioxidants and folinic acid showed no benefit to children with Down syndrome. But, the study does not use appropriate dosing levels of antioxidants and therefore cannot truly see what benefit supplementation has on children with Down syndrome.
The study used very low doses of antioxidants in these children. Oxidative stress is known to be a large part of Down syndrome. In order for antioxidant supplementation to really help the individual with Down syndrome, much higher doses of supplements need to be given.
I am not promoting “mega-vitamin therapy,” that is history. People just need to realize that higher doses (not mega doses though) of supplements need to be given to see much of any benefit.
It also should be noted that if someone reads the full text of the study, there were some differences between the children who took the supplements and the placebo group. The differences were not “statistically significant” so they are not reported in the abstract of the study or in the media.
Something else that needs to be acknowledged is the use of the RDA for people with Down syndrome. The RDA is for “generally all healthy people.” This may not include people with a genetic abnormality which may make their metabolism and biochemical needs different than the general population. Sure, the RDA may be a good guideline, but it cannot be used as the standard for people with Down syndrome. The researchers did note this in their study. They say that the doses that were given to the children “may have been inadequate to affect biochemical pathways.”
My 3 year old brother has Down syndrome. We give him Nutrivene-D Advanced Daily Antioxidant Supplement. It has proven to be extremely beneficial and helpful to him. It has changed his life dramatically. If it had not been for us starting him on Nutrivene-D at 8 months of age, he would not be as healthy and thriving as he is today.
I hope that people will not just believe all the news headlines that say all kinds of things ranging from “Supplements Don’t Help Down Babies,” to “Antioxidants don’t help Down syndrome,” or even “Supplements for Down’s children ‘Waste of cash’.” I know they are not a ‘waste of cash’ for my brother and many other children with Down syndrome.
~ Qadoshyah Fish
This study was flawed in that they did not use sufficient amounts of antioxidants to be of benefit. Even at the low amounts used there was some small benefit to those using the antioxidants.
My child with DS has taken Nutrivene-D for nearly 10 years. This supplement was developed specifically for people with DS and the amounts are beneficial, in particular to my child.
My child is healthy, and although her development is delayed, it is not excessively so. What else can we ask of vitamin use?
This BMJ study has little relevance to parents who use the currently available supplement products (Nutrivene-D and others) which target gene overexpression in Trisomy 21 for several reasons.
First, this study used only a tiny subset of the individual nutrients used in the “targeted nutritional intervention” (TNI) products. To compare the formulae tested with the formulae used by parents and sold by companies like International Nutrition and NutraChem is simply comparing apples and oranges. Conclusions about the one are simply irrelevant to the other. For more discussion of the difference in the formulae, see http://einsteinsyndrome.wordpress.com/2008/02/27/just-a-waste-of-cash/
Second, the developmental outcomes in the BMJ study would hardly be expected from the nutrients they chose to supplement. The tested nutrients would more likely be affecting health (antioxidants) and growth (folinic acid), rather than developmental milestones. Neither health nor growth were reported by the research team. The TNI products include a number of nutrients which target developmental outcomes, including the precurrsors to neurotransmitters. These were not used in this study, so it is no surprise that statisitcally significant developmental improvements did not appear. For more discussion on expected growth, see here: http://einsteinsyndrome.wordpress.com/2008/03/01/just-a-waste-of-cash-part-2/.
Third, this study included no baseline measurements for the babies in the study. Given the vast differences in developmental progress in babies with Trisomy 21, it is no surprise that one measurement averaged over 50 babies would have a large variation and not be statsically significant. If, however, the researchers had taken baselines, they could calculate differences in rates of development in individual children. The lack of baseline measurements makes it appear that there are no improvements. However, the raw data still shows improvement in the development with the supplemented group.
Fourth, the researchers appear concerned about long term negative results. Some long term negative results from using vitamin therapy in Down syndrome are reported here http://einsteinsyndrome.wordpress.com/2008/03/02/long-term-negative-outcomes-of-vitamin-therapy/.
I am not a representative of any company which sells vitamins, nor do I have any financial stake in these companies. I am simply a satisfied customer.
Our son, age 4 1/2 years, has Down Syndrome. For having DS he was high functioning at birth. Sadly he reacted to vaccines. It took a while for us to figure out what was happening, but once we stopped vaccinating he stopped having huge downturns in developement. Anyway after the two and four month vaccines he went from the 95% developementally (according to his pediatrician) down to the 5% dev. (according to Luth. Gen. Hospital in Park Ridge, IL) in just 10 weeks. We were sent home by Luth. Gen. being told to “do therapy”. The M.D. in charge told me she didn’t take stock in supplements. Our son was still deteriorating at home and I knew in my heart that external therapy wasn’t the answer. It was all heartbreaking. We prayed and I did what was on my heart. I supplemented him with oils - DHA, vitamin E, cod liver oil, lutein and some others. In just TWO DAYS our son showed signs of some recovery. His eyes stopped flying in his head and our sweet son who used to roll over and belly crawl but who could now no longer do any of that slowly lifted his little head to me on day two and I got just a hint of a smile. If only the M.D.’s could have done a tenth of what supplements did for our son I would have KISSED their feet! In just six weeks he was developing well again and Early Intervention assessed him at around the 70%. Even his skin had cleared up. I realize our son’s case is extreme because of vaccine reaction… but he has Down Syndrome and boy did supplements help. I would like to add that using supplements for a person who is highly oxidated (everyone with DS is) just makes sense. We use supplements with our son and we see improvements again and again. Here’s a good website for Down Syndrome info. - http://www.einsteinsyndrome.wordpress.com Blessings, Ali (ps - autism is occurring at a higher rate in Down Syndrome compared to the general population. Please research and think twice and thrice before vaccinating. http://www.mercola.com)