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NCT00873925 · ClinicalTrials.gov registry record · Phase 1

Cord Blood Plus Vitamin D and Omega 3s in T1D

A Phase 1 study of Type 1 Diabetes, sponsored by University of Florida.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT00873925 is a Phase 1 study of Type 1 Diabetes that has completed, run by University of Florida. The registered enrollment target is 15 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00873925, a Phase 1 study of Type 1 Diabetes, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

In this pilot study the investigators are trying to see if a single intravenous infusion of autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty acid supplementation can preserve beta cell function (prolong "honeymoon") in children with type 1 diabetes. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control. 15 Subjects will be randomized such that 2 of every 3 (10 total) will receive cord blood plus vitamin D and Omega 3 while 1 of 3 (5 total) will serve as controls and will not receive cord blood, vitamin D, or Omega 3 supplementation. The study will involve 5 visits over 1 year to the University of Florida This study is a follow-up to our initial study of cord blood infusion alone in which 23 children received autologous cord blood. The initial study was 100% safe but additional studies like the one described above are needed to determine how to improve cord blood based therapy.

Conditions Studied

Type 1 Diabetes

Interventions

  • DIETARY_SUPPLEMENT Vitamin D
  • BIOLOGICAL Autologous UCB
  • DIETARY_SUPPLEMENT Omega 3 FA

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2009-03
Est. Completion 2012-10
Phase Phase 1

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT00873925

The ClinicalTrials.gov registry entry for NCT00873925 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Vitamin D is the first listed.

NCT00873925 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00873925 about?

NCT00873925 is a clinical study titled "Cord Blood Plus Vitamin D and Omega 3s in T1D". In this pilot study the investigators are trying to see if a single intravenous infusion of autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty acid supplementation can preserve beta cell function (prolong "honeymoon") in children with type 1 diabetes. All subj...

What is the current status of trial NCT00873925?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2009-03. Estimated completion is 2012-10.

What conditions does trial NCT00873925 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT00873925?

The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Autologous UCB (BIOLOGICAL), Omega 3 FA (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00873925?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00873925 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.