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Completed

NCT Number: NCT03146273

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Israel

Tel Aviv, Central District, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean fractional absorption

    Time frame: 6 hours

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

Secondary outcomes

  1. Absorption rate

    Time frame: 6 hours

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

Sponsors and collaborators

Lead sponsor

Galilee CBR

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 9, 2017
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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