Omega-3 and Vitamin D Supplements in Childhood T1D
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Was assessed the comparability of cases and controls at baseline for gender, age, body
      weight, HbA1c% and device for insulin therapy.

      The preparation of omega-3 administered was a highly purified fish oil to avoid pollutants,
      containing a mixture of omega-3 long chain fatty acids standardized for contents of
      eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a 2: 1 ratio, in capsules or in
      liquid form. The liquid preparation was used in the case of difficulties in swallowing
      capsules or concomitant celiac disease because it was certified as gluten-free (Ener Zone
      Omega 3 RX® Equipe Enervit). The preparations contained antioxidants to preserve omega-3
      LCFA, tocopherol (1 mg in 1 g of omega-3 LCFA), palmitate, and rosemary extract. EPA and DHA
      were administered at 50-60 mg/kg/day for 12 months. The investigation of Arachidonic Acid
      (AA)/EPA ratios was performed in cases on recruitment (T0), and repeated after 3 (T3), 6
      (T6), and 12 months (T12).

      Cholecalciferol supplementation was fixed at 1000 IU/day (25 mcg/day), both in cases and
      controls. Vitamin D level was determined as 25(OH)D level at the clinical onset of T1D, at
      T0, T3, T6, and T12 in cases, and at clinical onset of controls.
    

Intervention name(s): omega-3 supplementation; Vitamin D supplementation
Intervention type(s): Drug; Drug
Intervention description(s): Supplementation with Ω-3, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 50-60 mg/kg/day for 12 months, currently underway or completed after 12 months of omega-3 administration, in 22/64 T1D children; Cholecalciferol 1000 IU/die
Other intervention name(s): Ener Zone Omega 3 RX® Equipe Enervit
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A cohort study was performed in 2017, in all T1D patients 1-18 years old with onset in the years 2014-2017. Supplementation with omega3 was proposed to all subjects with onset in 2017. Patients with onset in 2014-2015-2016 were enrolled only as control subjects. The work was performed on retrospectively collected data in medical records for patients with start of the disease in 2014-2016. Patients enrolled since 2017 have been studied prospectively.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: omega3; T1D remission period; honeymoon period; AA/EPA ratio