CLINICAL TRIAL: NUTRITIONAL INTERVENTION TO PREVENT TYPE 1 DIABETES PILOT TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Type 1 Diabetes (T1D) is caused by organ specific autoimmunity resulting from a gene-environment interaction. The genetics are fairly well delineated, with a high-risk association with the human leukocyte antigen HLA-DR3 and DR4. There are also one or more elusive "environmental" factors that we still do not understand. Observations have been made that children who have received omega-3 fatty acid supplementation have a lower risk of T1D. Omega-3 fatty acids could have a proactive effect that may occur during pregnancy, during infancy or both. We hypothesize that supplementation with docosahexaenoic acid (DHA), an omega-3 fatty acid; will prevent autoantibody development in children at genetic risk for T1D. We propose that the mechanism for this putative protection is due to DHA mediated suppression of the inflammatory response. We suggest that participant at risk for T1D have an increased proinflammatory environment, and propose that DHA administration will result in the inhibition of inflammation-related factors. This would block the early events associated with the subsequent development of autoimmunity in genetically at-risk subjects. The study is a two-arm multicenter, randomized, double-masked controlled clinical trial. The study drug is docosahexaenoic acid (DHA), an omega-3, polyunsaturated, 22-carbon fatty acid. The placebo is neutral vegetable control oil. A sample size of 90 participants will be randomly assigned in approximately equal number to the 2 groups (experimental treatment of control group). About half of the study participants will receive the DHA study substance daily and the other half will receive the control. The total length of the study is 3 years. All mothers will have follow up every 3 months. Nursing mothers will have follow up every 3 months until the infant is 1 year old. Infants will have follow up every 6 months for 3 years.