Treatment with antioxidants at onset of type 1 diabetes in children: a randomized, double-blind placebo-controlled study

Background In recent years different types of immune interventions have bee n tried at the onset of type 1 diabetes. Although some have shown effects, none have proven to be sufficiently effective to justify the inherent risks and side effects. Antioxidants have no or minimal side effects. If they ca n protect the beta cells against free oxygen radicals during the inflammato ry process this would be a safe and cheap intervention. To evaluate this hy pothesis a combination of various antioxidative agents was employed in a do uble-blind randomized study. Methods The study group comprised 46 children aged 1-17 years at diagnosis. They were followed for 3 years: 2 years whilst taking the tablets and 1 ye ar of follow-up. Twenty-four children were randomly allocated to active tre atment with high doses of antioxidants and 22 children to placebo tablets. The tablets were the same size and tasted identical. Results Twenty patients had for more than 1 month an insulin dose <0.5 U/kg in parallel with a normal HbA(1c) value and stable blood glucose values, b ut with no difference observed between those with and without active treatm ent. Nor was any significant difference observed regarding C-peptide values , fasting as well as stimulated. Whilst the antioxidants demonstrated no po sitive effect, they also had no negative side effects. Conclusion At diagnosis of type 1 diabetes in children, high doses of antio xidative agents have no effect either on the preservation of beta cell func tion or on metabolic balance. Copyright (C) 2001 John Wiley & Sons, Ltd.