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CompletedNCT04054505Updated Jul 10, 2024

Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.

An interventional study of EZPAK and Placebo in Vitamin Deficiency, sponsored by Optimal Health Research. Completed at 1 site in United States. Open to participants aged 26 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Optimal Health Research · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2019, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
275
Allocation
Randomized
Ages
26 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to correlate the findings of an early study with current data.

02

Conditions studied

  • Vitamin Deficiency

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03

In context

Avitaminosis

103 studies on the registry are indexed under Avitaminosis; 7 are open to participants now.

This study's enrollment of 275 is above the median of 71 across 75 interventional studies indexed under Avitaminosis.

Browse Avitaminosis studies →

Lead sponsor

Optimal Health Research is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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 -

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
275 participants (actual)

Study arms

  • Active comparator
    Vitamin A

    Rise or fall of Vitamin A after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin E

    Rise or fall of Vitamin E after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin B1

    Rise or fall of Vitamin B1 after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin B2

    Rise or fall of Vitamin B2 after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin B6

    Rise or fall of Vitamin B6 after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin B12

    Rise or fall of Vitamin B12 after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin C

    Rise or fall of Vitamin C after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Vitamin D

    Rise or fall of Vitamin D after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Calcium

    Rise or fall of Calcium after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • Active comparator
    Iron

    Rise or fall of Iron after three months

    Dietary Supplement: EZPAK · Dietary Supplement: Placebo

  • No intervention
    IGF1

    Rise or fall of IGF1 after three months

  • No intervention
    FT-3

    Rise or fall of FT-3 after three months

Interventions

  • Dietary supplementEZPAK

    One packet with breakfast for three months

  • Dietary supplementPlacebo

    One packet with breakfast for three months

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Three months

Secondary outcomes

  1. Control group

    Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.

    Time frame: Three months

  2. Placebo group

    Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.

    Time frame: Three months

07

Study locations

1 site
  • Optimal Health Research
    Salt Lake City, Utah 84117, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04054505
Lead sponsor
Optimal Health Research
Responsible party
Sponsor
First posted
Aug 13, 2019
Start date
Jan 2, 2019
Primary completion
Dec 28, 2020
Completion
Jan 4, 2021
Last update
Jul 10, 2024

Study contacts

Steven Osguthorpe, ND
principal investigator · Optimal Health Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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