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

Not Applicable

• Conditions: Vitamin Deficiency
• Interventions: Dietary Supplement: Multivitamins

• Registration Number: NCT03146273
• Lead Sponsor: Galilee CBR

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.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-06
• Study First Submitted QC: 2017-05-06
• Last Update Submitted: 2017-05-06
• Study Start: 2017-05-09
• Study First Posted: 2017-05-09
• Last Update Posted: 2017-05-09
• Primary Completion: 2017-06-10
• Study Completion: 2017-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet	Multivitamins	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.
Gel	Multivitamins	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.

Primary Outcome Measures

Name	Time	Method
Mean fractional absorption	6 hours	A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).

Secondary Outcome Measures

Name	Time	Method
Absorption rate	6 hours	A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).

Trial Locations

Locations (1)

Israel; 🇮🇱 Tel Aviv, Central, Israel