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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin Deficiency
• Intervention / Treatment: Dietary supplement: EZPAK; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin A; Rise or fall of Vitamin A after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin E; Rise or fall of Vitamin E after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin B1; Rise or fall of Vitamin B1 after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin B2; Rise or fall of Vitamin B2 after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin B6; Rise or fall of Vitamin B6 after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin B12; Rise or fall of Vitamin B12 after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin C; Rise or fall of Vitamin C after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Vitamin D; Rise or fall of Vitamin D after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Calcium; Rise or fall of Calcium after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
Active Comparator: Iron; Rise or fall of Iron after three months	Dietary supplement: EZPAK; One packet with breakfast for three months; Dietary supplement: Placebo; One packet with breakfast for three months
No Intervention: IGF1; Rise or fall of IGF1 after three months
No Intervention: FT-3; Rise or fall of FT-3 after three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control group	Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.	Three months
Placebo group	Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.	Three months

Collaborators and Investigators

• Sponsor: Optimal Health Research
• Investigators: Principal Investigator: Steven Osguthorpe, ND, Optimal Health Research

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): January 4, 2021

Study Registration Dates

• First Submitted: August 10, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Avitaminosis
• Other Study ID Numbers: EZ102018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes