A comparative Bioavailability study of multi vitamin formulations in Healthy Human Volunteers.

A Randomized, Single-Dose, Double-Blind, Active-Controlled, Three-Way Crossover Study to Assess the Oral Bioavailability of Fermented Liposomal Multivitamin Supplementation in Healthy Volunteers. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068755

Enrollment

Registered

2024-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fermented Liposomal Multivitamin: One day, single-dose oral administration of Fermented Liposomal Multivitamin Control Intervention1: Unformulated Multivitamin: One day, single-dose ora

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with Body mass index (BMI) of 18-25 kg/m2. 2. Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 3. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Subjects who have consumed food rich in Vitamin A, D and B5, 2 days prior to screening. 2.History of consumption medications known to interact with Multivitamin. 3.Subjects having symptoms of viral infection. 4.Pregnant or lactating women. 5.History of •Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis, Kidney disease, kidney stones, cardiac conditions, Recent blood donation (within 1 month) ,Current smoker or has quit smoking within last 3 months,Alcoholism and/or drug abuse, or heavy drinkers ,Immunodeficiency disease,Allergy, medication or supplement use that influences the immune system 6.Subjects with known hypersensitivity to the investigational products. 7.Subjects who have participated in any clinical trial in the past 1 month. 8.Any subjects found to have entered into the study in violation of this protocol or if the subject is uncooperative during the study. 9.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.

Design outcomes

Primary

Measure	Time frame
To estimate the plasma concentrations of Vitamin A, Vitamin D and Pantothenic acid (Vit B5) following supplementation of Fermented Liposomal Multivitamin, unformulated Multivitamin or placebo in healthy volunteers.Timepoint: Period 1 ( Day 1), Period 2 ( Day 8), Period 3 (Day 15)	—

Secondary

Measure	Time frame
The safety and tolerability of Fermented Liposomal Multivitamin supplementation.Timepoint: Period 1 ( Day 1), Period 2 ( Day 8), Period 3 (Day 15)	—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results