Vitamin D Deficiency Clinical Trial
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
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. ;
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