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

Primary Purpose

Vitamin Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EZPAK

Placebo

About this trial

This is an interventional health services research trial for Vitamin Deficiency

Eligibility Criteria

26 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Optimal Health Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Active Comparator

No Intervention

Arm Label

Vitamin A

Vitamin E

Vitamin B1

Vitamin B2

Vitamin B6

Vitamin B12

Vitamin C

Vitamin D

Calcium

Iron

IGF1

FT-3

Arm Description

Rise or fall of Vitamin A after three months

Rise or fall of Vitamin E after three months

Rise or fall of Vitamin B1 after three months

Rise or fall of Vitamin B2 after three months

Rise or fall of Vitamin B6 after three months

Rise or fall of Vitamin B12 after three months

Rise or fall of Vitamin C after three months

Rise or fall of Vitamin D after three months

Rise or fall of Calcium after three months

Rise or fall of Iron after three months

Rise or fall of IGF1 after three months

Rise or fall of FT-3 after three months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Control group

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

Placebo group

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

Full Information

NCT ID

NCT04054505

First Posted

August 10, 2019

Last Updated

January 5, 2021

Sponsor

Optimal Health Research

1. Study Identification

Unique Protocol Identification Number

NCT04054505

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 2, 2019 (Actual)

Primary Completion Date

December 28, 2020 (Actual)

Study Completion Date

January 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Optimal Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin Deficiency

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Triple blind

Masking

ParticipantCare ProviderInvestigator

Masking Description

Unmarked plan packet

Allocation

Randomized

Enrollment

275 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin A

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin A after three months

Arm Title

Vitamin E

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin E after three months

Arm Title

Vitamin B1

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin B1 after three months

Arm Title

Vitamin B2

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin B2 after three months

Arm Title

Vitamin B6

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin B6 after three months

Arm Title

Vitamin B12

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin B12 after three months

Arm Title

Vitamin C

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin C after three months

Arm Title

Vitamin D

Arm Type

Active Comparator

Arm Description

Rise or fall of Vitamin D after three months

Arm Title

Calcium

Arm Type

Active Comparator

Arm Description

Rise or fall of Calcium after three months

Arm Title

Iron

Arm Type

Active Comparator

Arm Description

Rise or fall of Iron after three months

Arm Title

IGF1

Arm Type

No Intervention

Arm Description

Rise or fall of IGF1 after three months

Arm Title

FT-3

Arm Type

No Intervention

Arm Description

Rise or fall of FT-3 after three months

Intervention Type

Dietary Supplement

Intervention Name(s)

EZPAK

Intervention Description

One packet with breakfast for three months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

One packet with breakfast for three months

Primary Outcome Measure Information:

Title

Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.

Description

Effectiveness of EZPAK in Raising Circulating Serum Levels

Time Frame

Three months

Secondary Outcome Measure Information:

Title

Control group

Description

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

Time Frame

Three months

Title

Placebo group

Description

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

Time Frame

Three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Osguthorpe, ND

Organizational Affiliation

Optimal Health Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Optimal Health Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34540877

Citation

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.

Results Reference

derived

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

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