Vitamin DeficiencyNCT04054505
Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
A study testing EZPAK in people with Vitamin Deficiency, run by Optimal Health Research at 1 site in United States.
Trial summary
The purpose of this study is to correlate the findings of an early study with current data. Read more about this study
- Who is it for?
- Ages 26 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin Deficiency
- What is being tested?
- EZPAK
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 4 Jan 2021
- 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 26 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Healthy volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF-1 and FT-3 are within normal limits.
A1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL
Exclusion Criteria: Volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3 are outside normal limits.
A1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Analysis of Clinical Data for the Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
The purpose of this study is to correlate the findings of an early study with current data.
- Conditions
- Vitamin Deficiency
- Being tested
- EZPAK, Placebo
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZPAKDietary supplement
One packet with breakfast for three months
PlaceboDietary supplement
One packet with breakfast for three months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Active comparator | Rise or fall of Vitamin A after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin E | Active comparator | Rise or fall of Vitamin E after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin B1 | Active comparator | Rise or fall of Vitamin B1 after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin B2 | Active comparator | Rise or fall of Vitamin B2 after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin B6 | Active comparator | Rise or fall of Vitamin B6 after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin B12 | Active comparator | Rise or fall of Vitamin B12 after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin C | Active comparator | Rise or fall of Vitamin C after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Vitamin D | Active comparator | Rise or fall of Vitamin D after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Calcium | Active comparator | Rise or fall of Calcium after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| Iron | Active comparator | Rise or fall of Iron after three months Receives: Dietary Supplement: EZPAK; Dietary Supplement: Placebo |
| IGF1 | No intervention | Rise or fall of IGF1 after three months |
| FT-3 | No intervention | Rise or fall of FT-3 after three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.
Effectiveness of EZPAK in Raising Circulating Serum Levels
Measured: Three months
Secondary outcomes (2)
Control group
Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.
Measured: Three months
Placebo group
Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start2 Jan 2019
- Primary completion28 Dec 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimal Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Osguthorpe, ND, Principal investigator, Optimal Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054505
- Sponsor's protocol ID
- EZ102018
- Status last verified
- Jul 2024
- First submitted
- 10 Aug 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nenseth HZ, Sahu A, Saatcioglu F, Osguthorpe S. A Nutraceutical Formula Is Effective in Raising the Circulating Vitamin and Mineral Levels in Healthy Subjects: A Randomized Trial. Front Nutr. 2021 Sep 1;8:703394. doi: 10.3389/fnut.2021.703394. eCollection 2021.
PubMed 34540877
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of Clinical Data for the Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
- ClinicalTrials.gov ID
- NCT04054505
- Acronym / sponsor ID
- EZ102018
- Conditions
- Vitamin Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Optimal Health ResearchUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 13 Aug 2019 (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.
The purpose of this study is to correlate the findings of an early study with current data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
- Model description
- Triple blind
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin A after three months |
| Vitamin E | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin E after three months |
| Vitamin B1 | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin B1 after three months |
| Vitamin B2 | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin B2 after three months |
| Vitamin B6 | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin B6 after three months |
| Vitamin B12 | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin B12 after three months |
| Vitamin C | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin C after three months |
| Vitamin D | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Vitamin D after three months |
| Calcium | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Calcium after three months |
| Iron | Active comparator | Dietary Supplement: EZPAK, Dietary Supplement: PlaceboRise or fall of Iron after three months |
| IGF1 | No intervention | –Rise or fall of IGF1 after three months |
| FT-3 | No intervention | –Rise or fall of FT-3 after three months |
Who may qualify
- Ages
- 26 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EZPAKOne packet with breakfast for three months | Dietary supplement | Calcium, Iron, Vitamin A, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6, Vitamin C, Vitamin D, Vitamin E |
| PlaceboOne packet with breakfast for three months | Dietary supplement | Calcium, Iron, Vitamin A, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6, Vitamin C, Vitamin D, Vitamin E |
Primary outcome
Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.
Time frame: Three months
Effectiveness of EZPAK in Raising Circulating Serum Levels
2 secondary outcomes
Control group
Time frame: Three months
Placebo group
Time frame: Three months
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 10 Jul 2024.
- Derived from this study: PubMed 34540877Nenseth HZ, Sahu A, Saatcioglu F, Osguthorpe S. A Nutraceutical Formula Is Effective in Raising the Circulating Vitamin and Mineral Levels in Healthy Subjects: A Randomized Trial. Front Nutr. 2021 Sep 1;8:703394. doi: 10.3389/fnut.2021.703394. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Steven Osguthorpe, ND principal investigator
Optimal Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZPAK in people with Vitamin Deficiency, run by Optimal Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jul 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 United States. 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?
Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04054505, which also lists 1 linked publication.
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 10 Jul 2024.