Omega-3 and Vitamin D Supplements in Childhood T1D
Status:
Completed
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
The study was conducted in 64 patients with T1D of which 26 had the onset in 2017, and 38 in
2016, 2015 and 2014. All received vitamin D 1000 IU /day since disease's onset. Moreover in
the 2017 group omega-3 were supplemented, starting within 3 and 6 months from the disease's
outbreak, and those were considered cases; the other 38 were enrolled as controls. Four cases
and one control dropped out. Finally in 59/64 were compared data of glycosylated hemoglobin
percentage (HbA1c%), average insulin daily requirement (IU/Kg/day), and IDAA1c [Insulin Daily
dose Adjusted for HbA1c, a surrogate index of residual endogen insulin secretion, calculated
as insulin daily dose (IU/Kg/24 h) x 4 + HbA1c%] at recruitment (T0), and 3 (T3), 6 (T6), 12
(T12) months after. T0 in cases was at the start of supplementation of omega-3, and
consequently 3, 6 and 12 months after; in controls were found data in clinical records of
outpatient beginning from the 3rd month and 3-6-12 months thereafter. Then 22 cases and 37
controls were compared.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita