Status:
COMPLETED
Nutritional Intervention to Prevent Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
Up to 5 years
Phase:
NA
Brief Summary
Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (is...
Detailed Description
There are two possible entry pathways for study participants. The first pathway is the entry point for pregnant mothers in their third trimester (24 weeks gestational age) whose babies may be at highe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00333554
Start Date
June 1 2006
End Date
April 1 2013
Last Update
April 29 2020
Active Locations (9)
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1
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital of Orange County
Orange, California, United States, 92868-3835
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, United States, 46202