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Randomized double-blind intervention trial to assess the efficacy of vitamin D3 supplementation vs placebo in reducing hepatic steato-inflammation and cardio-metabolic risk profile in patients affected by type 2 diabetes and non-alcoholic fatty liver disease (NAFLD/NASH)

Randomized double-blind intervention trial to assess the efficacy of vitamin D3 supplementation vs placebo in reducing hepatic steato-inflammation and cardio-metabolic risk profile in patients affected by type 2 diabetes and non-alcoholic fatty liver disease (NAFLD/NASH)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003010-17-IT
Enrollment
Unknown
Registered
2012-03-07
Start date
2011-07-07
Completion date
Unknown
Last updated
2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH) MedDRA version: 14.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: DIBASE*OS GTT 10ML 10000UI/ML Pharmaceutical Form: Oral drops, solution INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration unit: U uni

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged between 25 and 65 years Diagnosis of Type 2 Diabetes Mellitus Presence of ultrasound detected fatty liver confirmed by MRI acceptance of informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: e 65 years History of alcohol abuse (> 40 mg / day for men,> 20 mg / day for women) Acute or chronic liver infections autoimmune hepatitis History of cancer Other causes of liver disease (hemochromatosis, Wilson's disease) renal failure Hyper / hypoparathyroidism chronic enteropathies Hypersensitivity to any of the excipients or cholecalciferol hypercalcemia, hypercalciuria (nephrolithiasis, nephrocalcinosis) Therapy with vitamin D, calcium or other drugs affecting bone metabolism, calcium and vitamin D metabolism (anticonvulsants, glucocorticoids, antacids containing aluminum, cholestyramine ) Pregnancy and lactation

Design outcomes

Secondary

MeasureTime frame
Secondary end point(s): The secondary objective of this study is to assess changes in the cardio-metabolic risk profile in diabetic patients treated with Vitamin D oral supplementation;Timepoint(s) of evaluation of this end point: 12 months—

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of oral supplementation with cholecalciferol in improving liver steato-inflammation in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH.;Secondary Objective: To evaluate the efficacy of oral supplementation with cholecalciferol in improving cardio-metabolic risk profile (insulin-sensitivity, lipids, sistemic inflammation, glucose tolerance, body fat distribution) in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH.;Primary end point(s): Reduction of hepatic steatosis in patients with NAFLD and reduction in steatosis, inflammation and liver fibrosis in patients with NASH treated with Vitamin D oral supplementation;Timepoint(s) of evaluation of this end point: 12 months—

Countries

Italy

Contacts

Public ContactDott.ssa Maria Gisella Cavallo

Sapienza Universita' di Roma

gisella.cavallo@uniroma1.it3207172510

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026