Cord Blood Plus Vitamin D and Omega 3s in T1D
Cord Blood Plus Vitamin D and Omega 3s in T1D
NCT ID: NCT00873925 Phase: PHASE1 Status: COMPLETED Enrollment: 15 Completion: 2012-10
Conditions
Type 1 Diabetes
Interventions
Autologous UCB, Omega 3 FA, Vitamin D
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.
Primary Outcome
C-Peptide following the 1 year mixed meal tolerance test