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Trial record 58 of 76 for:    Long-chain fatty acids

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
Sponsor:
Collaborator:
University of Eastern Piedmont
Information provided by (Responsible Party):
Francesco Cadario, MD, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: omega-3 supplementation Drug: Vitamin D supplementation Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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.
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CASES
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




Primary Outcome Measures :
  1. 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)

  2. 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).

  3. 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%

  4. 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

  5. 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%

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
University of Eastern Piedmont
Investigators
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Principal Investigator: Francesco Cadario, MD Pediatric Clinic of AOU Novara
  Study Documents (Full-Text)

Documents provided by Francesco Cadario, MD, Azienda Ospedaliero Universitaria Maggiore della Carita:
Study Protocol  [PDF] January 1, 2017
Statistical Analysis Plan  [PDF] January 1, 2017
Informed Consent Form  [PDF] January 1, 2017


Additional Information:
Publications:
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Responsible Party: Francesco Cadario, MD, MD Division of Pediatrics, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03911843     History of Changes
Other Study ID Numbers: AOU Novara
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in the publication will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Francesco Cadario, MD, Azienda Ospedaliero Universitaria Maggiore della Carita:
omega3
T1D remission period
honeymoon period
AA/EPA ratio

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents