Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)

A Pharmacokinetic Crossover Comparison Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)

This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol

Study Overview

• Status: Completed
• Conditions: Vitamin Deficiency
• Intervention / Treatment: Dietary supplement: Multivitamins

Detailed Description

This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals:

1. Tablet/capsule administration - up to 20 healthy volunteers will be recruited to the study. The tablet/capsule will be administered as a single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
2. Gel administration - the gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Central
    • Tel Aviv, Central, Israel
      • Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female and aged 18-65 years
• BMI - 19-24
• Subject is not pregnant and is not nursing
• Signed Informed Consent Form

Exclusion Criteria:

• Current use of multivitamin or mineral complexes (washout of 4 days before Visit 2 is permitted)
• Participants with known vitamins or mineral deficiencies
• Diabetes Type II
• Smoking
• Subjects who have undergone surgery within the last 3 months.
• Subjects with a clinically significant (during last 3 months) infectious, immune-mediated or active malignant disease.
• Subjects who are receiving an elemental diet or parenteral nutrition.
• Subjects who are treated with insulin.
• Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
• Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
• Known sensitivity to any ingredients in the study product
• History of addiction or drug abuse
• Alcoholic regular use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tablet; The tablet/capsule will be administered as a single dose of Multivitamins in tablet after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs. The results will be used for the AUC calculation of the absorption in order to compare with the Gel administration absorption.	Dietary supplement: Multivitamins; After the study product administration blood tests will be performed in order to calculate the AUC for each mineral and vitamin - Vit A Vit E Folic Acid Vit C Calcium Magnesium After the washout period, the same procedure will be done for the additional formulation of the multivitamins.
Active Comparator: Gel; The gel will be administrated to the same group of patients in the single dose of Multivitamins in gel after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs. The results will be used for the AUC calculation of the absorption in order to compare with the Tablet administration absorption.	Dietary supplement: Multivitamins; After the study product administration blood tests will be performed in order to calculate the AUC for each mineral and vitamin - Vit A Vit E Folic Acid Vit C Calcium Magnesium After the washout period, the same procedure will be done for the additional formulation of the multivitamins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean fractional absorption	A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption rate	A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).	6 hours

Collaborators and Investigators

• Sponsor: Galilee CBR

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2017
• Primary Completion (Actual): June 10, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 6, 2017
• First Submitted That Met QC Criteria: May 6, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Avitaminosis
• Other Study ID Numbers: SSPA-17-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study results will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No