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

NCT03146273 | Completed

• 1 other identifier: SSPA-17-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin Deficiency

Outcome Measures

Primary Outcomes (1)

• Mean fractional absorption

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

  6 hours

Secondary Outcomes (1)

• Absorption rate

  6 hours

Study Arms (2)

Tablet

ACTIVE COMPARATOR

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

Gel

ACTIVE COMPARATOR

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

Interventions

Multivitamins 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; Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galilee CBR: lead

Study Sites (1)

Israel

Tel Aviv, Central District, Israel

Location

MeSH Terms

Conditions

Avitaminosis

Interventions

Geritol

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 9, 2017
• Study Start: May 9, 2017
• Primary Completion: June 10, 2017
• Study Completion: July 1, 2017
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)