Omega-3 and Vitamin D Supplements in Childhood T1D

NCT ID: NCT03911843

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-12-31

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CASES

Of eligible subjects, 26/64 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

Group Type: EXPERIMENTAL

omega-3 supplementation

Intervention Type: DRUG

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

Vitamin D supplementation

Intervention Type: DRUG

Cholecalciferol 1000 IU/die

CONTROLS

Others 38/64 subjects joined to the study as data contributors, and were entered as controls (CONTR).

Group Type: ACTIVE_COMPARATOR

Vitamin D supplementation

Intervention Type: DRUG

Cholecalciferol 1000 IU/die

Interventions

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 22/64 T1D children

Intervention Type: DRUG

Vitamin D supplementation

Cholecalciferol 1000 IU/die

Intervention Type: DRUG

Other Intervention Names

Ener Zone Omega 3 RX® Equipe Enervit

Eligibility Criteria

Inclusion Criteria

• All T1D patients aged 1-18 years whose disease onset had been in 2017, 2016, 2015, 2014 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Eastern Piedmont

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Francesco Cadario, MD

MD Division of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Cadario, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Clinic of AOU Novara

References

Cadario F, Savastio S, Ricotti R, Rizzo AM, Carrera D, Maiuri L, Ricordi C. Administration of vitamin D and high dose of omega 3 to sustain remission of type 1 diabetes. Eur Rev Med Pharmacol Sci. 2018 Jan;22(2):512-515. doi: 10.26355/eurrev_201801_14203.

Reference Type: BACKGROUND

PMID: 29424911 (View on PubMed)

Baidal DA, Ricordi C, Garcia-Contreras M, Sonnino A, Fabbri A. Combination high-dose omega-3 fatty acids and high-dose cholecalciferol in new onset type 1 diabetes: a potential role in preservation of beta-cell mass. Eur Rev Med Pharmacol Sci. 2016 Jul;20(15):3313-8.

Reference Type: BACKGROUND

PMID: 27467009 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://clinicaltrials.gov/ct2/show/NCT03406897

Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients (POSEIDON)

Other Identifiers

AOU Novara

Identifier Type: -

Identifier Source: org_study_id