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

Optimal Health Research

Status: Completed

Conditions: Vitamin Deficiency

Treatments: Dietary Supplement: EZPAK; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04054505

EZ102018

Details and patient eligibility

About

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

Enrollment: 275 patients

Sex: All

Ages: 26 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 -

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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275 participants in 12 patient groups

Vitamin A

Active Comparator group

Description:

Rise or fall of Vitamin A after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin E

Active Comparator group

Description:

Rise or fall of Vitamin E after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin B1

Active Comparator group

Description:

Rise or fall of Vitamin B1 after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin B2

Active Comparator group

Description:

Rise or fall of Vitamin B2 after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin B6

Active Comparator group

Description:

Rise or fall of Vitamin B6 after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin B12

Active Comparator group

Description:

Rise or fall of Vitamin B12 after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin C

Active Comparator group

Description:

Rise or fall of Vitamin C after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Vitamin D

Active Comparator group

Description:

Rise or fall of Vitamin D after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Calcium

Active Comparator group

Description:

Rise or fall of Calcium after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

Iron

Active Comparator group

Description:

Rise or fall of Iron after three months

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: EZPAK

IGF1

No Intervention group

Description:

Rise or fall of IGF1 after three months

FT-3

No Intervention group

Description:

Rise or fall of FT-3 after three months