NCT05394207

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 ways. It is evident that the immune system and the microbiome are interconnected, and that vitamin D is a critical intermediary player in this dynamic . Probiotics were shown to increase vitamin D intestinal absorption and increase vitamin D receptor protein expression and transcriptional activity . Likewise, vitamin D receptor status seems to be crucial in regulating the mechanisms of action of probiotics and modulating their anti-inflammatory, immunomodulatory and anti-infective benefits, suggesting a two-sided pathway . The objective of this study is to assess the different absorption of Vitamin D (Vit. D) between patients treated with Vit. D supplementation combined to a probiotic containing L. casei DG® and patients treated with Vitamin D supplementation and placebo

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 24, 2022

Last Update Submit

April 11, 2023

Conditions

Vitamin D Deficiency

Keywords

25-hydroxyvitamin D- 25(OH) DENTEROLACTISfood supplementLactobacillus paracasei CNCM I-1572probiotic

Outcome Measures

Primary Outcomes (1)

  • Serum levels of vitamin D (25-hydroxyvitamin D- 25(OH) D) measured in ng/mL

    Modification of the serum level of Vit. D in patients treated with L. casei DG® plus Vitamin D compared to the group treated with Vitamin D plus placebo will be measured in ng/mL

    week 12

Secondary Outcomes (11)

  • Time to reach normal serum levels of Vit. D.

    week 12

  • Presence of L. casei DG® strain in faeces

    week 12

  • Modification from baseline of faecal microbiota in terms of indices of microbial α diversity

    week 12

  • Modification from baseline of faecal microbiota in terms of indices of microbial β diversity

    week 12

  • Modification from baseline of faecal microbiota in terms of indices of microbial relative taxonomic abundance

    week 12

  • +6 more secondary outcomes

Other Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    week 16

Study Arms (2)

GROUP 1 (Investigational product)

EXPERIMENTAL

23 patients Investigational product: L. casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.

Dietary Supplement: L. casei DG® (Lactobacillus paracasei CNCM I-1572)

GROUP 2 (Comparator)

PLACEBO COMPARATOR

23 patients The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.

Other: placebo

Interventions

L. casei DG® (Lactobacillus paracasei CNCM I-1572)DIETARY_SUPPLEMENT

L. casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.

GROUP 1 (Investigational product)
placeboOTHER

The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.

GROUP 2 (Comparator)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rashid Hospital

Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Silvia Porta

CONTACT

+39 02909362 1silvia.porta@sofarfarm.it

Laura Patrucco

CONTACT

+39 02909362 1laura.patrucco@sofarfarm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigational and comparator product have similar appearance. All study products will be packaged in identical packs with identical labelling, except for the randomization number. Study patients, the clinical team, statisticians and the Sponsor will be blinded during the entire study until database lock. Only the Production Department of Sponsor will be un-blinded as necessary to perform labelling.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-Blind, Exploratory, Randomized, Controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 12, 2023

Record last verified: 2022-05

Locations

AE(1)