Phase 3
Completed N=64
Omega-3 and Vitamin D Supplements in Childhood T1D
Source: ClinicalTrials.gov NCT03911843 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Daily Insulin Need (IU/Kg/Day) and Daily Insulin Pre-meal Demand (Pre-meal IU/Kg/Day) at 12 Months — 0.49; 0.63; 0.22; 0.34 IU/Kg/day — p=<0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Insulin Need (IU/Kg/Day) and Daily Insulin Pre-meal Demand (Pre-meal IU/Kg/Day) at 12 Months |
0.49; 0.63; 0.22; 0.34 | <0.05 sig |
| PRIMARY HbA1c Percentage |
7.4; 7.8 | <0.05 sig |
| PRIMARY Number of Participants With Insulin Demand Adjusted for HbA1c %(IDAA1c) <9 |
12; 7 | <0.05 sig |
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
Data sourced from ClinicalTrials.gov (NCT03911843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.