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NCT00333554 · ClinicalTrials.gov registry record · NA

Nutritional Intervention to Prevent Diabetes

A NA study of Type 1 Diabetes Mellitus, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
NA
Development phase
99
Enrollment target
9
Study locations

NCT00333554: Completed NA study of Type 1 Diabetes Mellitus, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00333554 is a NA study of Type 1 Diabetes Mellitus that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 99 participants, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (42% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00333554, a NA study of Type 1 Diabetes Mellitus, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
NA
Development phase
99 participants
Enrollment target
9
Study locations

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

Type 1 Diabetes Mellitus

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

FieldValue
Enrollment Target 99 participants
Start Date 2006-06
Est. Completion 2013-04
Phase NA
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

490 total trials

What the finished NCT00333554 record still lists

NCT00333554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (42% lower).

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.

NCT00333554 lists 9 locations in 7 states (California, Indiana, Iowa).

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.

What interventions are being tested in trial NCT00333554?

The interventions under investigation include: DHA Treatment (DIETARY_SUPPLEMENT), Placebo for DHA (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00333554?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Type 1 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00333554's enrollment target sits among peer trials

99 34th of 112 higher than 79 of 112 other Type 1 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00333554, the US trial registry maintained by the National Library of Medicine. NCT00333554 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.