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

Vitamin Deficiency Clinical Trial

Official title:

Quantitative Analysis of Clinical Data for the Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054505
• Other study ID #: EZ102018
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: January 4, 2021

Study information

• Verified date: January 2021
• Source: Optimal Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: January 4, 2021
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Avitaminosis
• Vitamin Deficiency

Intervention

Dietary Supplement:
• EZPAK
One packet with breakfast for three months
• Placebo
One packet with breakfast for three months

Locations

Country	Name	City	State
United States	Optimal Health Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Optimal Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Control group	Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.	Three months
Secondary	Placebo group	Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.	Three months