Cord Blood Plus Vitamin D and Omega 3s in T1D
Completed · Phase 1
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT00873925
- Run by
- University of Florida
- People needed
- 15
- Starts
- 2009-03-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2013-04-04
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- TID diagnosis confirmed by presence of at least 1 diabetes autoantibody Children ≥ 1 years
- Stored autologous umbilical cord blood (15 sought) in an AABB and/or FACT accredited cord bank.
- Stimulated C-peptide > 0.2pmol/L on MMTT
- Cord blood meets all selection and testing criteria (see below).
- Normal screening values for CBC, Renal function and electrolytes (BMP with Ca, Mg, and Phos).
- Willing to comply with intensive diabetes management
You may not qualify if…
- Complicating medical issues that would interfere with blood drawing or monitoring.
- Chronic use of steroids or other immunosuppressive agents for other conditions.
- Positive infectious disease markers from mother's blood or cord at time of -collection (See below for details).
- Any evidence of illness on planned infusion date (i.e. fever >38.5 C, vomiting, diarrhea, wheezing, or crackles).
- Allergy to DHA (Omega 3) or Vitamin D
- Hypercalcemia
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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