Status:
UNKNOWN
Evaluation Of The Effect Of L. Casei DG® On Vitamin D Absorption In Patients Under Vitamin D Supplementation.
Lead Sponsor:
SOFAR S.p.A.
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Vitamin D deficiency is one of the most underdiagnosed and undertreated medical condition worldwide . The microbiome and vitamin D deeply influence each other and the immune system in many different w...
Detailed Description
The present study is a monocentric, exploratory, randomized, double-blind, controlled study to evaluate the effects of daily intake of L. Casei DG® (L. Paracasei CNCM I1572) on vitamin D absorption in...
Eligibility Criteria
Inclusion
- Male and female adults aged ≥ 18 and ≤ 60 years;
- Middle East Area residency;
- Serum levels of Vit. D≤ 20 ng/ml at screening, for which a course of Vitamin D at a dose of 4.000 U.I. daily has been prescribed as per clinical practice;
- Body Mass Index (BMI) between 18,50 and 29,99;
- Acceptance of the study by the patient and written informed consent to participate in the study provided.
Exclusion
- Serum level of Vit. D \> 20ng/ml;
- Documented malabsorption of Vit. D and/or other oligoelements and vitamins;
- BMI ≤ 18.5 and ≥29,99;
- Hypersensitivity to cholecalciferol or to any of the excipients of the prescribed drug;
- Contraindications to Vit. D supplementation (e.g. hypercalcemia, hypercalciuria, renal failure);
- Vit. D therapy or prophylaxis within 30 days before the enrolment in this study;
- History of administration of systemic antibiotics or antibiotics at bowel action (es: rifaximin) within 30 days before the enrolment in this study;
- History of administration of probiotics, prebiotics, (including probiotic/prebiotic enriched foods) within 30 days before the enrolment in this study;
- Present treatment with Proton Pump Inhibitors (PPIs) and aluminium-containing antacids;
- Present treatment with drugs interfering on the absorption of Vit. D, as barbiturates, antiepileptics (i.e. phenobarbital, phenytoin, carbamazepine), corticosteroids, antimycotics (i.e. ketoconazole, fluconazole), anti-retroviral agents, cholestyramine, colestipol, orlistat;
- Patients with certain or suspected diagnosis of chronic inflammatory bowel diseases, cystic fibrosis or mucoviscidosis;
- Patients with hepatic impairment (Alanine transaminase (ALT) or Aspartate aminotransferase (AST)\>3 times the upper limit of normal);
- Patients with nephrolithiasis or nephrocalcinosis;
- Infective gastro-intestinal syndromes in active phase or gastro-intestinal infectious residue which can alter the bowel absorption on the judgement of the investigator;
- Episodes of viral or bacterial enteritis within 2 months before the enrolment in the study;
- History or presence of gastric and/or duodenal ulcers;
- Psychiatric syndromes and/or psychological disturbances;
- Any severe pathology which could interfere with the study treatment;
- Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the investigator may interfere with the participation to the study;
- Poor reliability or presence of conditions leading to a poor compliance/adherence to the protocol by the patient;
- Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable);
- Pregnancy and/or breastfeeding\*;
- Existence of mental illness or any mental condition potentially interfering with appropriate compliance with protocol procedures;
- Patients without self-judgement ability;
- Participation in another investigational study or treatment with any investigational drug within the previous 30 days;
- Recent history or suspicion of alcohol abuse or drug addiction;
- Patients not compliant with the procedures of the protocol.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05394207
Start Date
June 1 2023
End Date
June 1 2024
Last Update
April 12 2023
Active Locations (1)
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1
Rashid Hospital
Dubai, United Arab Emirates