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

NCT ID: NCT03146273

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2017-07-01

Brief Summary

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

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.

Conditions

Vitamin Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Multivitamins

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: ACTIVE_COMPARATOR

Multivitamins

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galilee CBR

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Israel

Tel Aviv, Central District, Israel

Countries

Israel

Other Identifiers

SSPA-17-1

Identifier Type: -

Identifier Source: org_study_id