Omega-3 and Vitamin D Supplements in Childhood T1D

NCT03911843 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AOU Novara
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

omega3; T1D remission period; honeymoon period; AA/EPA ratio

Outcome Measures

Primary Outcomes (3)

• Daily Insulin Need (IU/Kg/Day) and Daily Insulin Pre-meal Demand (Pre-meal IU/Kg/Day) at 12 Months

  The Daily Insulin Needs (IU/Kg/day), and the Daily Insulin Pre-meal Demand (Pre-meal IU/Kg/day) respectively represent the average total (sum of boluses and basal) and average pre-meal (sum of pre-meal boluses) insulin doses administered in one day to each patient. They have been calculated over a week, and were expressed in International Units / Kg of weight, higher values mean a worse outcome.

  12 months

• HbA1c Percentage

  percentage of glycated hemoglobin measured through the high-performance liquid chromatography (HPLC).

  12 months

• Number of Participants With Insulin Demand Adjusted for HbA1c %(IDAA1c) <9

  The IDAA1c (insulin daily dose adjusted for glycosylated hemoglobin percentage) was calculated as HbA1c percentage + average daily insulin dose (IU/kg/24 h) x 4. A score \<9 meet definition of partial remission and Residual Endogenic Insulin Secretion (REIS). IDAA1c represents a surrogate index of insulin secretion and of metabolic control. In a scale from 5 to 12, higher score mean a worse outcome (e.g. \<5.5 is expected in a normal individual, \<9 in an individual in partial remission. See reference).

  12 months

Study Arms (2)

CASES

EXPERIMENTAL

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

Drug: omega-3 supplementation; Drug: Vitamin D supplementation

CONTROLS

ACTIVE COMPARATOR

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

Drug: Vitamin D supplementation

Interventions

omega-3 supplementation 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

Also known as: Ener Zone Omega 3 RX® Equipe Enervit

CASES

Vitamin D supplementation DRUG

Cholecalciferol 1000 IU/die

CASES; CONTROLS

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• renal cysts
• sarcoidosis
• histoplasmosis
• hyperparathyroidis
• lymphoma
• tuberculosis
• Patients treated with drugs that could affect immunity or glucose metabolism, including corticosteroids, ciclosporin and tacrolimus

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• University of Eastern Piedmont: collaborator

Related Publications (2)

• 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.

  PMID: 29424911 BACKGROUND

• 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.

  PMID: 27467009 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study was not randomized and Controls were retrospective, whereby the comparability between Cases and Controls concerned only HbA1c percentage, Daily Insulin Needs (IU/Kg/day) and IDAA1c, indirect indices of residual endogen insulin secretion (REIS)

Results Point of Contact

• Title: Dr. Francesco Cadario, Head of the Pediatric Diabetology service
• Organization: Azienda Ospedaliero-Universitaria di Novara, Italy

francesco.cadario@gmail.com

+39 347 226 6507

Study Officials

• Francesco Cadario, MD

  Pediatric Clinic of AOU Novara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Division of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 11, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 19, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: the IPD and any additional supporting information will become available and for ten years, including the start and end dates or period of availability. This may be provided starting to date when data are published or otherwise made available.
• Access Criteria: adress the request to Central Contact Person