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Nutritional Intervention to Prevent Diabetes
NCT00333554 · View on ClinicalTrials.gov ↗
Study 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 (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. The autoimmune process is thought to be initiated by a gene-environment interaction. The genetics involved in the development of T1D are fairly well understood. There is a higher risk of developing T1D with the presence of the human leukocyte antigen (HLA) DR3 or DR4. It is also known that not everyone with these genes actually develops T1D. Therefore, one or more environmental factors are thought to contribute to the process of developing T1D. The consumption of the anti-inflammatory fatty acids, the omega-3 fatty acids, has decreased significantly in the past 100 years. At the same time a rise in the incidence of T1D, especially in young children has occurred. Because of the warnings to eliminate fish during pregnancy, pregnant women are consuming even less omega-3 fatty acids during fetal development. 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 protective effect that may occur during pregnancy, infancy, or both. The mechanism of this protection may be due to the DHA mediated suppression of the inflammatory response. Patients at higher risk for T1D have an increased pro-inflammatory environment. We hypothesize that DHA supplementation during pregnancy and early childhood will block the initial pro-inflammatory events and prevent development of islet cell autoimmunity in children at higher risk for T1D. This study is a feasibility study to determine if a full-scale DHA supplementation study will be implemented. If a full study is implemented, the primary outcome will be to determine if nutritional supplementation with omega-3 fatty acids during
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT DHA Treatment
- DIETARY_SUPPLEMENT Placebo for DHA
Study Locations (9)
California
- Childrens Hospital of Los Angeles — Los Angeles
- Children's Hospital of Orange County — Orange
- University of California, San Francisco — San Francisco
Indiana
- Indiana University-Riley Hospital for Children — Indianapolis
Iowa
- University of Iowa Health Care — Iowa City
Massachusetts
- Joslin Diabetes Center — Boston
Minnesota
- University of Minnesota — Minneapolis
Missouri
- The Children's Mercy Hospital — Kansas City
Utah
- Utah Diabetes Center — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2006-06 |
| Est. Completion | 2013-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00333554
The ClinicalTrials.gov registry entry for NCT00333554 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions — of which DHA Treatment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00333554 reports 9 study locations spanning 7 distinct geographic areas — top geographies include California, Indiana, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00333554 about?
NCT00333554 is a clinical study titled "Nutritional Intervention to Prevent Diabetes". 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 (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insuli...
What is the current status of trial NCT00333554?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2006-06. Estimated completion is 2013-04.
What conditions does trial NCT00333554 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00333554?
The interventions under investigation include: DHA Treatment (DIETARY_SUPPLEMENT), Placebo for DHA (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00333554?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00333554 being conducted?
This trial has 9 study locations across California, Indiana, Iowa, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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