Omega-3 and Vitamin D Supplements in Childhood T1D
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|ClinicalTrials.gov Identifier: NCT03911843|
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: omega-3 supplementation Drug: Vitamin D supplementation||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|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 between 2015-2017. Patients with onset in 2014 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|
|Official Title:||Omega 3 Long Chain Polyunsaturated Fatty Acids, Enriched Mediterranean Diet and Vitamin D Supplementation in Childhood Type 1 Diabetes: One Year Case-cohort Study|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Of eligible subjects, 45/67 started an intervention program with Ω-3 (CASES). 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
Drug: omega-3 supplementation
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 42/65 T1D children
Other Name: EnerZona Omega-3
Drug: Vitamin D supplementation
Cholecalciferol 1000 ui/die
Active Comparator: CONTROLS
Others 22/67 subjects joined to the study as data contributors, and were entered as controls (CONTR).
Drug: Vitamin D supplementation
Cholecalciferol 1000 ui/die
- Change from Baseline Plasma glucose levels to 12 months [ Time Frame: baseline, 12 months ]mg/dl; 1 mg/dl:0.05551 mmol/liter; gluco-oxidase colorimetric method (GLUCOFIX, by Menarini Diagnostics, Florence, Italy)
- Change from Baseline HbA1c% to 12 months [ Time Frame: baseline, 12 months ]measured through the high-performance liquid chromatography (HPLC), using a Variant machine (Biorad, Hercules, CA); ); intra- and inter-assay coefficients of variation are respectively lower than 0.6% and 1.6%. Linearity is excellent from 3.2% (11 mmol/mol) to 18.3% (177 mmol/mol).
- Change from Baseline vitamin D to 12 months [ Time Frame: baseline, 12 months ]measured by serum 25(OH)D assay, using an immunochemiluminescence (CLIA) method (DiaSorin Liaison® Test, Stillwater MN-USA); the coefficient of inter-individual variability of the method (CVa%) was 10%
- Change from Baseline Fatty acids to 12 months [ Time Frame: baseline, 12 months ]AA, EPA, DHA percentages and respective AA/EPA ratio were determined by high-resolution capillary gas chromatography in whole blood using dried blood spots testing
- Change from Baseline C-peptide to 12 months [ Time Frame: baseline, 12 months ]expressed in ng/ml, were measured, on citrate or heparinized plasma, both by chemiluminescent "sandwich" immunoassay (DiaSorin Liaison) and by immunochemiluminescence with automatic analyzer Immulite 2000, Medical Systems with coefficient of variability of 7.40%
- Change from Baseline IDAA1c to 12 months [ Time Frame: baseline, 12 months ]a composite index of insulin demand and metabolic control IDAA1c, calculated as HbA1c (%) + 4 insulin dose (UI/kg/24 h), was used. A score <9 meet definition of partial remission and REIS, according with the U.S. Food and Drug Administration, and previous studies in TrialNet
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911843
|Principal Investigator:||Francesco Cadario, MD||Pediatric Clinic of AOU Novara|