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Vitamin D Formulation
Regular Vitamin D3 1000IU for Vitamin D
N/A
Waitlist Available
Research Sponsored by Factors Group of Nutritional Companies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Awards & highlights
Study Summary
This trial is testing two different concentrations of vitamin D to see which is more effective. They are also testing a new microencapsulated LipoMicel Vitamin D formulation to see if it is more effective than the regular vitamin D formulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D
Secondary outcome measures
Safety blood work evaluation - change of C Reactive Protein (CRP)
Safety blood work evaluation - change of alanine aminotransferase (ALT)
Safety blood work evaluation - change of alkaline phosphatase
+8 moreTrial Design
4Treatment groups
Active Control
Group I: Regular Vitamin D3 1000IUActive Control1 Intervention
The first group receives regular Vitamin D3 1000IU
Group II: Microencapsulated Vitamin D3 1000IUActive Control1 Intervention
The second group receives microencapsulated Vitamin D3 1000IU
Group III: Regular Vitamin D3 2500IUActive Control1 Intervention
The third group receives regular Vitamin D3 2500IU
Group IV: Microencapsulated Vitamin D3 2500IUActive Control1 Intervention
The fourth group receives microencapsulated Vitamin D3 2500IU
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Who is running the clinical trial?
Factors Group of Nutritional Companies Inc.Lead Sponsor
7 Previous Clinical Trials
194 Total Patients Enrolled
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