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

NCT ID: NCT04054505

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2021-01-04

Brief Summary

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

Detailed Description

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Conditions

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Vitamin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Triple blind
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Unmarked plan packet

Study Groups

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Vitamin A

Rise or fall of Vitamin A after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin E

Rise or fall of Vitamin E after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin B1

Rise or fall of Vitamin B1 after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin B2

Rise or fall of Vitamin B2 after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin B6

Rise or fall of Vitamin B6 after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin B12

Rise or fall of Vitamin B12 after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin C

Rise or fall of Vitamin C after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Vitamin D

Rise or fall of Vitamin D after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Calcium

Rise or fall of Calcium after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Iron

Rise or fall of Iron after three months

Group Type ACTIVE_COMPARATOR

EZPAK

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

Placebo

Intervention Type DIETARY_SUPPLEMENT

One packet with breakfast for three months

IGF1

Rise or fall of IGF1 after three months

Group Type NO_INTERVENTION

No interventions assigned to this group

FT-3

Rise or fall of FT-3 after three months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EZPAK

One packet with breakfast for three months

Intervention Type DIETARY_SUPPLEMENT

Placebo

One packet with breakfast for three months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

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 -
Minimum Eligible Age

26 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optimal Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Osguthorpe, ND

Role: PRINCIPAL_INVESTIGATOR

Optimal Health Research

Locations

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Optimal Health Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34540877 (View on PubMed)

Other Identifiers

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EZ102018

Identifier Type: -

Identifier Source: org_study_id

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