Vitamin D DeficiencyNCT05394207
Evaluation Of The Effect Of L. Casei DG® On Vitamin D Absorption In Patients Under Vitamin D Supplementation.
A study testing L. casei DG® (Lactobacillus paracasei CNCM I-1572) in people with Vitamin D Deficiency, run by SOFAR S.p.A. at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- L. casei DG® (Lactobacillus paracasei CNCM I-1572)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jun 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Rashid Hospital
Dubai
Dr.Sameer Al Awadhi, Dr, +9714 219 1144, saalawadhi@dha.gov.ae
About this study
Official title: Evaluation Of The Effect Of L. Casei DG® (L. Paracasei CNCM I1572) On Vitamin D Absorption In Patients Under Vitamin D Supplementation. Double-Blind, Exploratory, Randomized, Controlled Clinical Trial.
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
Read the 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 adult patients with Vitamin D (Vit. D) deficiency, defined as a blood level of 25(OH) D ≤ 20 ng/ml.
The investigational product is ENTEROLACTIS®, a food supplement resulting from SOFAR research (listed in the Food Supplement Registry of the United Arab Emirates Ministry of Health \& Prevention with the code #12235-13911-2) available as drinkable vials of 10 ml, containing 8 billion of live cells of L. casei DG The comparator product is an identical drinkable vial of placebo. Vit. D will be provided by the sponsor as oral drops of 10. 000 U.I./mL 16 drops of Vit. D must be dissolved in the Investigational Product/placebo vial and then this has to be reconstituted and drunk immediately.
The patients will be involved in 10 on site visits: V-1 (Screening)- within 7 days before baseline visit, V0 (Baseline) at the start of therapy, V1- 1 week after the start of therapy, 6 visits (V2-V7) every two weeks and V8- follow up visit, 4 weeks after the end of treatment (EOT-V7).
Investigational Product/comparator treatment will start at V0 and will end at V7, for a duration of 12 weeks. After the End of Treatment visit (EOT-V7), patients will enter in a 4 weeks Follow Up (FU) period, for a total duration of the study of 16 weeks (12 weeks of treatment + 4 weeks of FUP). If a patient reaches normal levels of Vitamin D before EOT visit, study treatment will be interrupted, and patient will enter the FU period.
- Conditions
- Vitamin D Deficiency
- Being tested
- L. casei DG® (Lactobacillus paracasei CNCM I-1572), placebo
- Keywords
- 25-hydroxyvitamin D- 25(OH) D, ENTEROLACTIS, food supplement, Lactobacillus paracasei CNCM I-1572, probiotic
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. casei DG® (Lactobacillus paracasei CNCM I-1572)Dietary supplement
- casei DG® (Lactobacillus paracasei CNCM I-1572) containing 8 billion of live cells daily + Vitamin D 4.000 U.I. daily.
placeboOther
The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (11)
Time to reach normal serum levels of Vit. D.
Serum levels of vitamin D (25-hydroxyvitamin D- 25(OH) D) will be measured in ng/mL.
Measured: week 12
Presence of L. casei DG® strain in faeces
Presence of L. casei DG® strain in faeceswill be assessed by real time quantitative PCR (qPCR).
Measured: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial α diversity
Alpha-diversity will be measured by Shannon and Chao1 indexes
Measured: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial β diversity
Beta-diversity will be analyzed with the UniFrac algorithms and plotted applying non-metric multidimensional scaling (NMDS)
Measured: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial relative taxonomic abundance
The relative abundance of microbial taxa will be evaluated descriptively and graphically by treatment groups and by study visits to show the phyla, orders, genera and operational taxonomic units (OTUs) most commonly detected in the collected samples.
Measured: week 12
Modification from baseline of faecal short-chain fatty acid (SCFAs);
measurement of fecal levels (mmol/100g) of: lactate, acetate, succinate, propionate,butyrate,valerate, iso-valerate.
Measured: week 12
Modification of serum levels of Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10)
serum levels of Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10) will be measured in pg/mL
Measured: week 12
Modification of serum levels of C reactive protein (CRP)
serum levels of C reactive protein (CRP) will be measured in mg/mL
Measured: week 12
Modification of serum levels of zonulin
serum levels of zonulin measured in ng/mL;
Measured: week 12
Modification of serum levels of total cholesterol, LDL, HDL and triglycerides
serum levels of total cholesterol, LDL, HDL and triglycerides measured in mg/dL
Measured: week 12
Evaluate the overall patient satisfaction with treatment
Evaluate the overall satisfaction with treatment by means of Visual Analogue Scale (VAS) scale at V7. 10 cm scale where 0 not satisfied at all is and 10 is fully satisfied
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind, Exploratory, Randomized, Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOFAR S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394207
- Sponsor's protocol ID
- PSC-DS LacD3
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of L. Casei DG® (L. Paracasei CNCM I1572) On Vitamin D Absorption In Patients Under Vitamin D Supplementation. Double-Blind, Exploratory, Randomized, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05394207
- Acronym / sponsor ID
- PSC-DS LacD3
- Conditions
- Vitamin D Deficiency
- Keywords
- 25-hydroxyvitamin D- 25(OH) D, ENTEROLACTIS, food supplement, Lactobacillus paracasei CNCM I-1572, probiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- SOFAR S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 adult patients with Vitamin D (Vit. D) deficiency, defined as a blood level of 25(OH) D ≤ 20 ng/ml.
The investigational product is ENTEROLACTIS®, a food supplement resulting from SOFAR research (listed in the Food Supplement Registry of the United Arab Emirates Ministry of Health \& Prevention with the code #12235-13911-2) available as drinkable vials of 10 ml, containing 8 billion of live cells of L. casei DG The comparator product is an identical drinkable vial of placebo. Vit. D will be provided by the sponsor as oral drops of 10. 000 U.I./mL 16 drops of Vit. D must be dissolved in the Investigational Product/placebo vial and then this has to be reconstituted and drunk immediately.
The patients will be involved in 10 on site visits: V-1 (Screening)- within 7 days before baseline visit, V0 (Baseline) at the start of therapy, V1- 1 week after the start of therapy, 6 visits (V2-V7) every two weeks and V8- follow up visit, 4 weeks after the end of treatment (EOT-V7).
Investigational Product/comparator treatment will start at V0 and will end at V7, for a duration of 12 weeks. After the End of Treatment visit (EOT-V7), patients will enter in a 4 weeks Follow Up (FU) period, for a total duration of the study of 16 weeks (12 weeks of treatment + 4 weeks of FUP). If a patient reaches normal levels of Vitamin D before EOT visit, study treatment will be interrupted, and patient will enter the FU period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind, Exploratory, Randomized, Controlled
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (Investigational product) | Experimental | Dietary Supplement: L. casei DG® (Lactobacillus paracasei CNCM I-1572)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. |
| GROUP 2 (Comparator) | Placebo comparator | Other: placebo23 patients The comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | GROUP 1 (Investigational product) |
| placeboThe comparator product is an identical matching placebo daily + Vitamin D 4.000 U.I. daily. | Other | GROUP 2 (Comparator) |
Primary outcome
Serum levels of vitamin D (25-hydroxyvitamin D- 25(OH) D) measured in ng/mL
Time frame: week 12
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
11 secondary outcomes
Time to reach normal serum levels of Vit. D.
Time frame: week 12
Presence of L. casei DG® strain in faeces
Time frame: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial α diversity
Time frame: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial β diversity
Time frame: week 12
Modification from baseline of faecal microbiota in terms of indices of microbial relative taxonomic abundance
Time frame: week 12
Modification from baseline of faecal short-chain fatty acid (SCFAs);
Time frame: week 12
Modification of serum levels of Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10)
Time frame: week 12
Modification of serum levels of C reactive protein (CRP)
Time frame: week 12
Modification of serum levels of zonulin
Time frame: week 12
Modification of serum levels of total cholesterol, LDL, HDL and triglycerides
Time frame: week 12
Evaluate the overall patient satisfaction with treatment
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. casei DG® (Lactobacillus paracasei CNCM I-1572) in people with Vitamin D Deficiency, run by SOFAR S.p.A. at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Porta (+39 02909362 1, silvia.porta@sofarfarm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of vitamin D (25-hydroxyvitamin D- 25(OH) D) measured in ng/mL (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.