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

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

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

Conditions
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Vitamin Deficiency

Intervention / Treatment
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* Dietary Supplement: EZPAK
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Triple blind
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |