drugset / Trial / NCT03911843

Omega-3 and Vitamin D Supplements in Childhood T1D

NCT03911843

Non-randomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2017-01-01
Primary completion
2018-12-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Omega-3 fatty acids Unknown 50 mg/kg
Subject Omega-3 fatty acids Unknown 60 mg/kg
Background Cholecalciferol Other / unclassified 1000 iu