Vitamin DeficiencyNCT03146273
Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
A study testing Multivitamins in people with Vitamin Deficiency, run by Galilee CBR at 1 site in Israel.
Trial summary
This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin Deficiency
- What is being tested?
- Multivitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 9 May 2017to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female and aged 18-65 years
- BMI - 19-24
- Subject is not pregnant and is not nursing
- Signed Informed Consent Form
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Crossover Comparison 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
Read the 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.
- Conditions
- Vitamin Deficiency
- Being tested
- Multivitamins
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultivitaminsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Multivitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean fractional absorption
A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).
Measured: 6 hours
Secondary outcomes (1)
Absorption rate
A comparison of absorption rate across the two Multivitamin mineral formulations (gel vs. tablet/capsule).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start9 May 2017
- Primary completion10 Jun 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galilee CBR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146273
- Sponsor's protocol ID
- SSPA-17-1
- Status last verified
- Sep 2024
- First submitted
- 6 May 2017
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Crossover Comparison Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
- ClinicalTrials.gov ID
- NCT03146273
- Acronym / sponsor ID
- SSPA-17-1
- Conditions
- Vitamin Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galilee CBRIndustry (pharma, biotech, devices)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 10 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet | Active comparator | Dietary Supplement: MultivitaminsThe 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. |
| Gel | Active comparator | Dietary Supplement: MultivitaminsThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female and aged 18-65 years
- BMI - 19-24
- Subject is not pregnant and is not nursing
- Signed Informed Consent Form
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultivitaminsAfter 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. | Dietary supplement | Gel, Tablet |
Primary outcome
Mean fractional absorption
Time frame: 6 hours
A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).
1 secondary outcome
Absorption rate
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No. The study results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamins in people with Vitamin Deficiency, run by Galilee CBR at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean fractional absorption (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.