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

Vitamin Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03146273
• Other study ID #: SSPA-17-1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 6, 2017
• Last updated: May 6, 2017
• Start date: May 9, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: May 2017
• Source: Galilee CBR
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 1, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Vitamin Deficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galilee CBR

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean fractional absorption	A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).	6 hours
Secondary	Absorption rate	A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).	6 hours