Omega-3 and Vitamin D Supplements in Childhood T1D

A cohort study was performed at the Division of Pediatrics in 2017, University of East Piedmont (Novara, Piedmont, Italy). Seventy-eight children, 1-18 years, corresponding to all T1D patients with onset in the years 2014-2017, were eligible for the study: 8 were excluded because onset in another center, 2 already supplemented with Ω-3 before 2017, and one met an exclusion criteria. Finally 67 patients were consecutively recruited. Supplementation with Ω-3 was proposed to all subjects with onset between 2015-2017. Patients with onset in 2014 were enrolled only as control subjects. Of eligible subjects, 45/67 started an intervention program with Ω-3 (CASES), 2/45 CASES were excluded as drop-out (discontinued Ω-3 because taste), and one for side effects (diarrhea). Others 22/67 subjects joined to the study as data contributors, and were entered as controls (CONTR).

Finally, 64 subjects (M 29/F 35, mean 9,8 + 4.2 years at onset, Italians 53, Immigrants 11, East Europe 3, North Africa 7, Central Africa 2) with onset of T1D in 2014, 2015, 2016 and 2017 are going to be evaluated. Metabolic parameters (insulin requirement IU/Kg/day, HbA1c%) will be compared in two groups (CASES and CONTR) each 3-6 months from the onset. The work was performed on retrospectively collected data from medical records of patients with start of the disease in 2014-2016. Patients enrolled since 2017 (n=20) have been studied prospectively.

Moreover, a group of 30 health children were recruited as healthy controls (HC) (12.1 years old + 3.9, M19:F11, Caucasian 30, Immigrants 2) for AA, EPA, DHA values and AA/EPA ratio. They referred to the Pediatric Surgery or Orthopedic Clinics for minor surgery or mild trauma, recruited as voluntary.

The intervention consisted in supplementation with highly purified Ω-3, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 50-60 mg/kg/day for 12 months (n. 42). It is reported as (Ω3)0 the start if intervention for the each patient. The intervention with Ω-3 is considered concluded after one-year of Ω-3 supplementation (CASES) [(Ω-3)12]. Cases were divided into four sub-groups according to the time of overt disease onset (T0), n.20 within 6 months from onset in 2017, n.6 within 7-12 months from onset in 2016, n.6 within 13-18 months from onset in 2016 and n.10 within 19-36 months from onset in 2015.

Moreover a dietitian counseling was provided as educational intervention for selecting a diet that could provide a natural source of Ω-3 (blue fish, nuts, walnuts, poultry, eggs, vegetable oils, flax seeds and leafy vegetable). The goal of supplement and dietary advice was to target AA/EPA ratio between 1.5-3.

Cholecalciferol 1000 IU/day (25 mcg/day) supplementation for the management of Vitamin D deficiency/insufficiency was systematically added at onset in all T1D patients (n. 78).

The Vitamin D dosage was adjusted to target 25(OH)D level in the normal range according to Endocrine Society, 30-100 ng/ml (75-249 nmol/l) for all patients. Before supplementation of Vitamin D, at clinical onset of T1D, 25(OH)D level, and before of Ω-3 administration, AA/EPA ratio and fatty acids percentages were performed, and repeated after 3 and 12 months of supplementation.

At (Ω-3)0 and (Ω-3)12, fasting C-peptide (FC-P) levels, daily insulin dose (IU/Kg/day) and glycosylated hemoglobin (HbA1C%) both in supplemented and not supplemented patients (CONTR) will be compared.