Nutritional Intervention to Prevent Diabetes  (TrialNet)

This study is no longer recruiting patients. Pregnant women in their third trimester of pregnancy and infants 6 months of age or younger were eligible to enroll if there was a family history of type 1 diabetes.

This study is based on observations that children who have received more omega-3 fatty acid—-either in the womb or during the first year of life—-have a lower risk of developing type 1 diabetes. This pilot study is helping to inform the development of a full-scale study to test whether omega-3 fatty acids can protect children from developing type 1 diabetes. The enrolled infants or pregnant women will randomly be assigned to one of two groups: (1) daily omega-3 fatty acid supplements (in the form of docosahexaenoic acid, or DHA); or (2) placebo (no supplements).

This study is a feasibility study to determine if a full-scale omega-3 fatty acid supplementation study will be implemented.

Pregnant women or infants will be randomized to one of the two study groups: DHA supplementation (this is the intervention) or control (this is the placebo). The DHA to be used in this trial is produced from algae, not from fish oil, so there is no risk of mercury or pesticide contamination.

Pregnant and nursing mothers who are assigned to the control group will receive study capsules containing a vegetable oil and no DHA. Pregnant and nursing mothers who are assigned to the experimental group will receive study capsules containing DHA. During pregnancy and while breastfeeding, infants will receive the study substance indirectly through their mother (either the placenta or breastmilk).

Infants who are either partially or exclusively formula fed will receive study substance more directly through the study formula. The infants in the control group will receive study formula containing the typical amount of DHA that can be found in some infant formulas, while infants in the experimental group will receive study formula containing a larger amount of DHA than typically found in some infant formulas. By 6-12 months of age, all infants will get study supplement added to solid foods.

All mothers will have contact with the study site every 3 months. Nursing mothers will be asked to provide samples of breast milk for fatty acids analysis at these visits. Infants will need to come to follow-up study visits every 6 months. At each of these visits, the infant will have a limited physical exam and blood drawn from a vein to monitor immune activity, levels of fatty acid and vitamin D, and markers of type 1 diabetes.

You cannot participate in other studies while participating in this study.

Please call the toll free number below or visit the TrialNet website.