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 been 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 can protect the beta cells against free oxygen radicals during the inflammatory process this would be a safe and cheap intervention. To evaluate this hypothesis a combination of various antioxidative agents was employed in a double-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 year of follow-up. Twenty-four children were randomly allocated to active treatment 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, but with no difference observed between those with and without active treatment. Nor was any significant difference observed regarding C-peptide values, fasting as well as stimulated. Whilst the antioxidants demonstrated no positive effect, they also had no negative side effects.


CONCLUSIONS
At diagnosis of type 1 diabetes in children, high doses of antioxidative agents have no effect either on the preservation of beta cell function or on metabolic balance.
Ludvigsson
J
J
Division of Pediatrics, Department of Health and Environment, Linköping University, Linköping, Sweden. Johnny.ludvigsson@lio.se
Samuelsson
U
U
Johansson
C
C
Stenhammar
L
L
D000293:Adolescent; D017668:Age of Onset; D000975:Antioxidants / Q000627:therapeutic use*; D001323:Autoantibodies / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005968:Glutamate Decarboxylase / Q000276:immunology; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007223:Infant; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D010919:Placebos; D013997:Time Factors
D000975:Antioxidants; D001323:Autoantibodies; D005968:Glutamate Decarboxylase; D006442:Glycated Hemoglobin; D007328:Insulin; D010919:Placebos; C024211:islet cell antibody