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

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ClinicalTrials.gov Identifier: NCT03146273
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Vitamin Deficiency Dietary Supplement: Multivitamins Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Pharmacokinetic Crossover Comparison Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
Estimated Study Start Date : May 9, 2017
Estimated Primary Completion Date : June 10, 2017
Estimated Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: A
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.
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.


Experimental: B
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
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.





Primary Outcome Measures :
  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 Outcome Measures :
  1. Absorption rate [ Time Frame: 6 hours ]
    A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Galilee CBR
ClinicalTrials.gov Identifier: NCT03146273     History of Changes
Other Study ID Numbers: SSPA-17-1
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study results will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders