Nutritional Intervention to Prevent Diabetes

Plain-language summary

This study looks at whether a supplement of the omega-3 fatty acid DHA can help prevent type 1 diabetes in infants at risk, compared with a placebo (inactive substance). Pregnant mothers with a family history of type 1 diabetes and their at-risk infants were able to take part. Sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), this study had no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Intervention

DHA Treatment, Placebo for DHA

Start date

6/1/2006

Estimated completion

4/1/2013

Countries

United States

Related genes

Locations

• Los Angeles, United States
• Orange, United States
• San Francisco, United States
• Indianapolis, United States
• Iowa City, United States
• Boston, United States
• Minneapolis, United States
• Kansas City, United States
• Salt Lake City, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria

Pregnant mothers are eligible for enrollment into this study if they:

1. Have T1D or the child's father, or a full or half-sibling of the child has T1D
2. Are 18 years of age or older
3. Are in their third trimester of pregnancy (i.e. gestation is 24 weeks or longer)
4. Have understood and signed a written informed consent and HIPAA authorization
5. 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:

1. Are less than or equal to six months of age on the date of randomization
2. 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)
3. Have a parent or legal guardian who has understood and signed a written informed consent and HIPAA authorization
4. 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:

1. Have any condition the investigator believes will put the mother or her fetus at an unacceptable medical risk for participation in this study
2. Have a known complication of pregnancy causing an increased risk for the mother or fetus prior to entry into the study
3. Have previously had multiple (2 or more) pre-term births (\<36 weeks)
4. 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)
5. Plan to take DHA supplementation during the study

Infants are NOT eligible for enrollment into this study if they:

1. Have any condition the investigator believes will put the subject at an unacceptable medical risk for participation in this study
2. Have a mother with a condition the investigator believes will put her at an unacceptable medical risk for participation in this study
3. 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
4. Have a protective allele (DQB1\*0602 or DRB1\*0403)
5. Were born prior to 36 weeks gestation and require a pre-term infant formula