NCT04054505

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

August 10, 2019

Last Update Submit

July 8, 2024

Conditions

Vitamin Deficiency

Outcome Measures

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

    Three months

Secondary Outcomes (2)

  • Control group

    Three months

  • Placebo group

    Three months

Study Arms (12)

Vitamin A

ACTIVE COMPARATOR

Rise or fall of Vitamin A after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin E

ACTIVE COMPARATOR

Rise or fall of Vitamin E after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin B1

ACTIVE COMPARATOR

Rise or fall of Vitamin B1 after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin B2

ACTIVE COMPARATOR

Rise or fall of Vitamin B2 after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin B6

ACTIVE COMPARATOR

Rise or fall of Vitamin B6 after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin B12

ACTIVE COMPARATOR

Rise or fall of Vitamin B12 after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin C

ACTIVE COMPARATOR

Rise or fall of Vitamin C after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Vitamin D

ACTIVE COMPARATOR

Rise or fall of Vitamin D after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Calcium

ACTIVE COMPARATOR

Rise or fall of Calcium after three months

Dietary Supplement: EZPAKDietary Supplement: Placebo

Iron

ACTIVE COMPARATOR

Rise or fall of Iron after three months

Dietary Supplement: EZPAKDietary 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

Interventions

EZPAKDIETARY_SUPPLEMENT

One packet with breakfast for three months

CalciumIronVitamin AVitamin B1Vitamin B12Vitamin B2Vitamin B6Vitamin CVitamin DVitamin E
PlaceboDIETARY_SUPPLEMENT

One packet with breakfast for three months

CalciumIronVitamin AVitamin B1Vitamin B12Vitamin B2Vitamin B6Vitamin CVitamin DVitamin E

Eligibility Criteria

Age26 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimal Health Research

Salt Lake City, Utah, 84117, United States

Location

Related Publications (1)

  • 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.

    PMID: 34540877DERIVED

MeSH Terms

Conditions

Avitaminosis

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Steven Osguthorpe, ND

    Optimal Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Unmarked plan packet
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Triple blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2019

First Posted

August 13, 2019

Study Start

January 2, 2019

Primary Completion

December 28, 2020

Study Completion

January 4, 2021

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)