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Evaluation Of The Effect Of L. Casei DG® On Vitamin D Absorption In Patients Under Vitamin D Supplementation.

NCT05394207 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-04-12

No results posted yet for this study

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

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

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

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

OTHER

placebo

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

Sponsors & Collaborators

  • SOFAR S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394207 on ClinicalTrials.gov