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

Primary Purpose

Vitamin Deficiency

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Multivitamins

About this trial

This is an interventional prevention trial for Vitamin Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Mean fractional absorption

A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).

Secondary Outcome Measures

Absorption rate

A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).

Full Information

NCT ID

NCT03146273

First Posted

May 6, 2017

Last Updated

May 6, 2017

Sponsor

Galilee CBR

1. Study Identification

Unique Protocol Identification Number

NCT03146273

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 9, 2017 (Anticipated)

Primary Completion Date

June 10, 2017 (Anticipated)

Study Completion Date

July 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galilee CBR

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin Deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Multivitamins

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean fractional absorption

Description

A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Absorption rate

Description

A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The study results will be published.

Learn more about this trial

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

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