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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04054505
Enrollment
275
Registered
2019-08-13
Start date
2019-01-02
Completion date
2021-01-04
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin Deficiency

Brief summary

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

Interventions

DIETARY_SUPPLEMENTEZPAK

One packet with breakfast for three months

DIETARY_SUPPLEMENTPlacebo

One packet with breakfast for three months

Sponsors

Optimal Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Unmarked plan packet

Intervention model description

Triple blind

Eligibility

Sex/Gender
ALL
Age
26 Years to 75 Years
Healthy volunteers
Yes

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 -

Design outcomes

Primary

MeasureTime frameDescription
Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.Three monthsEffectiveness of EZPAK in Raising Circulating Serum Levels

Secondary

MeasureTime frameDescription
Control groupThree monthsLevels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.
Placebo groupThree monthsLevels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026