Omega-3 and Vitamin D Supplements in Childhood T1D

Omega 3 Long Chain Polyunsaturated Fatty Acids, Enriched Mediterranean Diet and Vitamin D Supplementation in Childhood Type 1 Diabetes: One Year Case-cohort Study

Sponsors

Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Collaborator: University of Eastern Piedmont

Source Azienda Ospedaliero Universitaria Maggiore della Carita
Brief Summary

Sixty-four participants (29 M, F 35, mean age 9.8+4.2) with T1D from January, the 1st 2017 were consecutively enrolled in a one year lasting series. Vitamin D supplement and Mediterranean diet were introduced since the onset of T1D (T0). Beginning in 2017, 42/67 subjects (20 within 6 months from onset in 2017, 6 within 7-12 months, plus 6 within 13-18 months from onset in 2016, and 10 within 19-36 months from onset in 2015) received an additional Ω-3 supplementation [(Ω-3)0] with eicosapentenoic acid (EPA) and docosahexaenoic acid (DHA) intake (50-60mg/kg/day), to achieve an Arachidonic Acid (AA)/EPA ratio of 1.5-3. Vitamin D [25(OH)D] blood levels and AA/EPA ratios were determined before Vitamin D and Ω-3 supplementations, and are repeated after three [(Ω-3)3] and twelve months [(Ω-3)12]. 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) are assessed and compared.

Detailed Description

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.

Overall Status Completed
Start Date January 1, 2017
Completion Date December 31, 2018
Primary Completion Date December 31, 2018
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline Plasma glucose levels to 12 months baseline, 12 months
Change from Baseline HbA1c% to 12 months baseline, 12 months
Change from Baseline vitamin D to 12 months baseline, 12 months
Change from Baseline Fatty acids to 12 months baseline, 12 months
Change from Baseline C-peptide to 12 months baseline, 12 months
Change from Baseline IDAA1c to 12 months baseline, 12 months
Enrollment 64
Condition
Intervention

Intervention Type: Drug

Intervention Name: omega-3 supplementation

Description: 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

Arm Group Label: CASES

Other Name: EnerZona Omega-3

Intervention Type: Drug

Intervention Name: Vitamin D supplementation

Description: Cholecalciferol 1000 ui/die

Eligibility

Criteria:

Inclusion Criteria: - All T1D patients aged 1-18 years whose disease onset had been in 2017, 2016, 2017 affering to the Pediatric Diabetology of AOU Novara (Italy) - written consents of parents - without assumption of omega 3 supplementation before 2017 Exclusion Criteria: - renal cysts - sarcoidosis - histoplasmosis - hyperparathyroidis - lymphoma - tuberculosis - Patients treated with drugs that could affect immunity or glucose metabolism, including corticosteroids, ciclosporin and tacrolimus

Gender: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Francesco Cadario, MD Principal Investigator Pediatric Clinic of AOU Novara
Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita

Investigator Full Name: Francesco Cadario, MD

Investigator Title: MD Division of Pediatrics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CASES

Type: Experimental

Description: 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

Label: CONTROLS

Type: Active Comparator

Description: Others 22/67 subjects joined to the study as data contributors, and were entered as controls (CONTR).

Patient Data Yes
Study Design Info

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 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.

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov