Nutritional Intervention to Prevent Diabetes (TN06)
Type 1 Diabetes Mellitus
About this trial
This is an interventional prevention trial for Type 1 Diabetes Mellitus focused on measuring DHA, docosahexaenoic acid, omega-3 fatty acid, fish oil, pregnancy, infancy, prevention, "at risk" for developing type 1 diabetes, juvenile diabetes, T1D, diabetes mellitus, Type 1 diabetes TrialNet, TrialNet, dietary supplementation, nutrition
Eligibility Criteria
Inclusion Criteria Pregnant mothers are eligible for enrollment into this study if they: Have T1D or the child's father, or a full or half-sibling of the child has T1D Are 18 years of age or older Are in their third trimester of pregnancy (i.e. gestation is 24 weeks or longer) Have understood and signed a written informed consent and HIPAA authorization Are willing to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control Infants are eligible for enrollment into this study if they: Are less than or equal to six months of age on the date of randomization Are found to be at risk for type 1 diabetes because they have a mother, father or full or half-sibling with T1D AND have a DR3 or DR4 allele OR have another relative (includes both 1st and 2nd degree relatives) with T1D (multiplex family) Have a parent or legal guardian who has understood and signed a written informed consent and HIPAA authorization Have a parent(s) or legal guardian(s) who are willing for their baby to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control Exclusion Criteria Pregnant mothers are NOT eligible for enrollment into this study if they: Have any condition the investigator believes will put the mother or her fetus at an unacceptable medical risk for participation in this study Have a known complication of pregnancy causing an increased risk for the mother or fetus prior to entry into the study Have previously had multiple (2 or more) pre-term births (<36 weeks) Are diabetic and have a known HbA1c greater than 9% at anytime during the pregnancy (however, healthy infants after birth may qualify in spite of the above restrictions during pregnancy) Plan to take DHA supplementation during the study Infants are NOT eligible for enrollment into this study if they: Have any condition the investigator believes will put the subject at an unacceptable medical risk for participation in this study Have a mother with a condition the investigator believes will put her at an unacceptable medical risk for participation in this study Have a nursing mother who plans to take DHA supplementation or has a parent or legal guardian who plans to provide supplementation to his/her infant independently during the study Have a protective allele (DQB1*0602 or DRB1*0403) Were born prior to 36 weeks gestation and require a pre-term infant formula
Sites / Locations
- Childrens Hospital of Los Angeles
- Children's Hospital of Orange County
- University of California, San Francisco
- Indiana University-Riley Hospital for Children
- University of Iowa Health Care
- Joslin Diabetes Center
- University of Minnesota
- The Children's Mercy Hospital
- Utah Diabetes Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DHA Treatment Group
Control Group
DHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child.
Placebo for DHA given to nursing mother (breast milk), study formula, or capsules (removing content and mixing with food)depending on age of child.