Clinical Trials Logo

Clinical Trial Summary

The primary objective of this study is to evaluate plasma concentrations of Vitamin D (25-hydroxyvitamin D; 1,25-dihydroxyvitamin D) of different Vitamin D formulations in healthy volunteers at two concentrations. Pharmacokinetic parameters (Serum 25(OH)D and 1,25(OH)2D ng/ml) are compared with those of a regular Vitamin D formulation and a new (microencapsulated) LipoMicel Vitamin D formulation. The secondary objective of this study is to evaluate safety blood parameters- The following blood parameters (serum levels) are checked: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. In addition, mineral levels-such as calcium, magnesium and phosphorus, potassium and sodium-are measured before and at the end of the study.

Clinical Trial Description

Study Design: At least 40 healthy volunteers of both sexes in the age range 21-65 participate in a parallel, randomized blinded study conducted with different vitamin D3 products. Each treatment is administered orally per day at a total dose of 1000 UI and 2500 IU vitamin d3 (cholecalciferol), together with breakfast, over a period of 30 days. Participants are randomly divided into 4 groups (at least 10 per group): The first group receives regular Vitamin D (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D (2500IU), the fourth receives microencapsulated D3 (2500 IU). Plasma concentrations (serum levels) of Vitamin D (25(OH)D and 1,25(OH)2D ng/ml are measured at baseline-before treatment start (day 0), during treatment (day 5, 10 and 15; one blood collection per day) and at end of treatment (day 30). After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60. The entire study session will span the course of 60 days. Participants are asked to attend 7 visits at LifeLabs to collect venous blood samples. Each Vitamin D treatment is consumed with a glass of water along with breakfast for a period of 30 days. Safety blood work is performed upon study enrolment, at the end of the Vitamin supplementation (day 30)- and at the end of the study (day 60) at Life Labs. The following blood parameters are checked and must be within normal ranges to participate the study: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. Mineral levels-such as calcium, magnesium and phosphorus-are measured before and at the end of the study (day 30). All participants must understand written and spoken English and give written informed consent before any study speciļ¬c procedure will be carried out. All tested products are formulation manufactured by Factors Group. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05209425
Study type Interventional
Source Factors Group of Nutritional Companies Inc.
Status Completed
Phase N/A
Start date January 1, 2022
Completion date April 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05186194 - The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures. N/A
Recruiting NCT06101147 - Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome Phase 2
Completed NCT02904421 - 6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation
Completed NCT02092701 - Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period N/A
Completed NCT05748249 - Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence Phase 1
Recruiting NCT04844957 - Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS Early Phase 1
Completed NCT05313477 - The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With TDF Phase 4
Completed NCT01170572 - Longitudinal Study of Patients Following Long Bone Fracture N/A
Not yet recruiting NCT01080950 - Vitamin D Zinc Fever N/A
Active, not recruiting NCT04564625 - Relationships Between Vitamin D and Orthopedic Trauma
Not yet recruiting NCT01992263 - Vitamin D Supplementation and TB N/A
Completed NCT00938600 - Antenatal Vitamin D3 Dose-finding and Safety Study Phase 1
Completed NCT04535791 - Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers Phase 3
Completed NCT04502667 - Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19 Phase 3
Recruiting NCT05448365 - Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid Phase 3
Recruiting NCT03533010 - Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation N/A
Recruiting NCT04404842 - Development of a Screening Tool for the Risk of Vitamin D Deficiency
Recruiting NCT05208827 - Vitamin D Supplementation for the Prevention of GDM Early Phase 1
Withdrawn NCT03073369 - Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease Phase 4
Completed NCT02361827 - The Effect of Vitamin D on in Vitro Fertilization Outcome