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

Not Applicable

Completed

• Conditions: Vitamin Deficiency
• Interventions: Dietary Supplement: EZPAK; Dietary Supplement: Placebo

• Registration Number: NCT04054505
• Lead Sponsor: Optimal Health Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Study First Submitted: 2019-08-10
• Study First Submitted QC: 2019-08-10
• Study First Posted: 2019-08-13
• Primary Completion: 2020-12-28
• Study Completion: 2021-01-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E	EZPAK	Rise or fall of Vitamin E after three months
Vitamin E	Placebo	Rise or fall of Vitamin E after three months
Vitamin B1	EZPAK	Rise or fall of Vitamin B1 after three months
Vitamin C	EZPAK	Rise or fall of Vitamin C after three months
Vitamin D	EZPAK	Rise or fall of Vitamin D after three months
Vitamin D	Placebo	Rise or fall of Vitamin D after three months
Calcium	EZPAK	Rise or fall of Calcium after three months
Iron	EZPAK	Rise or fall of Iron after three months
Iron	Placebo	Rise or fall of Iron after three months
Vitamin B6	EZPAK	Rise or fall of Vitamin B6 after three months
Vitamin B12	EZPAK	Rise or fall of Vitamin B12 after three months
Vitamin B12	Placebo	Rise or fall of Vitamin B12 after three months
Vitamin C	Placebo	Rise or fall of Vitamin C after three months
Vitamin B2	EZPAK	Rise or fall of Vitamin B2 after three months
Vitamin A	EZPAK	Rise or fall of Vitamin A after three months
Vitamin B1	Placebo	Rise or fall of Vitamin B1 after three months
Vitamin B6	Placebo	Rise or fall of Vitamin B6 after three months
Vitamin A	Placebo	Rise or fall of Vitamin A after three months
Vitamin B2	Placebo	Rise or fall of Vitamin B2 after three months
Calcium	Placebo	Rise or fall of Calcium after three months

Primary Outcome Measures

Name	Time	Method
Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.	Three months	Effectiveness of EZPAK in Raising Circulating Serum Levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Optimal Health Research; 🇺🇸 Salt Lake City, Utah, United States