Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Eastern Piedmont | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| CONTROLS | Active Comparator | Others 38/64 subjects joined to the study as data contributors, and were entered as controls (CONTR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco Cadario, MD | Pediatric Clinic of AOU Novara | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29424911 | Background | 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. | |
| 27467009 | 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. |
| Label | URL |
|---|---|
| Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients (POSEIDON) | View source |
Not provided
all IPD that underlie results in the publication will be shared
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.
adress the request to Central Contact Person
Not provided
Not provided
The recruitment started 03/17/2017 with the enrollment of the first patient, and ended on 06/08/2019 with the end of the omega-3 supplementation period of the last enrolled patient. All participants were introduced since the beginning of T1D to tailored insulin therapy, to Mediterranean diet (according to a standardized item detailed in reference), and received 1000 IU/day of vitamin D supplementation.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CASES New T1D Onsets 2017 | All the New T1D Onsets 2017 received a further supplementation of ultra refined fish oil, enriched in LC-PUFA omega 3, containing standardized concentrations EPA + DHA (2:1), at 60 mg/kg/day. The supplementation with omega 3 started within 3th and 6th months after the clinical T1D onset and lasted one year. |
| FG001 | CONTROLS Previous T1D Onsets | All Previous T1D Onsets (2014-2016) receiving vitamin D and Mediterranean diet without omega 3 supplementation, were continuously recruited. Retrospectively their available data from 3th and 6th months from the clinical onset to T1D, for the following year, were compared. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only the subjects who finished the study contributed to the result
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CASES | The T1D onsets were eligible subjects, of which 26/64 new onsets 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 60 mg/kg/day for 12 months. The supplementation with omega 3 started within 3th and 6th months of T1D clinical onset and lasted one year. They had been introduced to the Mediterranean diet according to a standardized item and received 1000 IU/day of vitamin D supplementation since the beginning of T1D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | IU/Kg/day | 12 months |
|
The observation interval of side effects was in each case into the period of omega-3 supplementation (T0-T12), lasting 12 months, and into a comparable period in the controls.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CASES New T1D Onsets 2017 | All the New T1D Onsets 2017 received Mediterranean diet, vitamin D 1000 IU/day, and a further supplementation of ultra refined fish oil, enriched in LC-PUFA omega 3, containing standardized concentrations EPA + DHA (2:1), at 60 mg/kg/day. The supplementation with omega 3 started within 3th and 6th months after the clinical T1D onset and lasted one year. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| persistent diarrhea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | the diarrhea started soon after the start of omega 3 supplementation, that was interrupted. The diarrhea lasted 2 weeks |
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)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francesco Cadario, Head of the Pediatric Diabetology service | Azienda Ospedaliero-Universitaria di Novara, Italy | +39 347 226 6507 | francesco.cadario@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2017 | Apr 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2017 | Apr 9, 2019 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2017 | Apr 9, 2019 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Vitamin D supplementation | Drug | Cholecalciferol 1000 IU/die |
|
| Lost to Follow-up |
|
| BG001 | CONTROLS | The Previous T1D onsets, 38/64 subjects joined to the study as controls (CONTROLS). They received vitamin D supplementation 1000 IU/day and Mediterranean diet according to a standardized item since the onset of T1D, without omega 3; retrospectively their available data from 3th and 6th months of overt disease for the following year, were compared |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | CONTROLS Previous T1D Onsets | All Previous T1D Onsets (2014-2016) receiving vitamin D and Mediterranean diet without omega 3 supplementation, were continuously recruited. Retrospectively their available data from 3th and 6th months from the clinical onset to T1D, for the following year, were compared. |
|
|
|
| Primary | HbA1c Percentage | percentage of glycated hemoglobin measured through the high-performance liquid chromatography (HPLC). | Posted | Mean | Standard Deviation | percentage of HbA1c | 12 months |
|
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 1 |
| 26 |
| EG001 | CONTROLS Previous T1D Onsets | All Previous T1D Onsets (2014-2016) receiving vitamin D and Mediterranean diet without omega 3 supplementation, were continuously recruited. Retrospectively their available data from 3th and 6th months from the clinical onset to T1D, for the following year, were compared. | 0 | 37 | 0 | 37 | 0 | 38 |
|
| transient suppression of TRH | Endocrine disorders | SNOMED CT | Systematic Assessment | in one teenager girl with pre-existing autoimmune thyroiditis, a transient suppression of TRH was found, lasting 3 months after omega 3 suspension |
|
| an extension of the aPTT clotting | Blood and lymphatic system disorders | SNOMED CT | Non-systematic Assessment | an extension of the aPTT clotting time at the end of the supplementation period was verified. |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |