- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03444155
Natural Versus Synthetic Vitamin B Complexes in Human
Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design:
Monocentric double-blind experiment
Scientific background:
Vitamin B-complex is water-soluble and essential for humans. Vitamin B deficiency is associated with neurologic diseases, heart insufficiency, diminished hormone production and maldigestion. Due to the fact that literature search did not reveal distinct information about natural versus synthetic Vitamin B-complexes this study was initiated to investigate bioavailability and long-term effects of natural Vitamin B-complexes in comparison to synthetic Vitamin B-complexes.
Vitamin B complex was filled in hydroxypropylmethylcellulose capsules (size 0, ivory-coloured). Daily dose = 3 capsules in the morning with 250ml water.
Blinding/Randomization:
The person in charge for manufacturing and blinding arranged an identical packaging of both verum as well as synthetic Vitamin B-complex. Each package consists of 126 capsules per subject and period. Each product was tagged with the subject-number and period (period I and period II).
Study-subjects were blinded by the person in charge for randomization through a sealed envelope. The allocation was in the relation of 1:1 between group A (verum in period I and synthetic Vitamin B-complex in period II) and group B (synthetic Vitamin B-complex in period I and verum in period II). The ultimate subject list was forwarded to the person in charge for randomization after the run-in phase.
Method:
Blood sampling:
Blood (max. 20ml) was collected in a seated position from an antecubital vein.
Time schedule:
Run-in-phase: 3 weeks (no supplementation) Determination of inclusion criteria, nutrition advice, randomization.
Phase I: 6 weeks (supplementation) Group A - natural Vitamin B-complex supplementation every day Group B - synthetic Vitamin B-complex supplementation every day
Blood sampling:
First day:
Fasting value (basic) - Vitamin B-complex supplementation - After 1.5 hours After 4 hours After 7 hours
End of first supplementation:
After 6 weeks
Wash-out period: 2 weeks (without supplementation)
Phase II: 6 weeks (supplementation) Group A - synthetic Vitamin B-complex supplementation every day Group B - natural Vitamin B-complex supplementation every day
Blood sampling:
First day:
Fasting value (basic) - Vitamin B-complex supplementation - After 1.5 hours After 4 hours After 7 hours
End of second supplementation:
After 6 weeks
Wash-out period II: 6 weeks (without supplementation) Final exam - last blood sampling
Drop-out-criteria:
Drawback Compliance (<80% of Vitamin B-complexes) Supplementation of Vitamin B-complexes during run-in-phase or wash-out periods
Primary-target parameters:
Serum concentrations for vitamins B1, B2, B6, B9 and B12
Secondary-target biomarkers:
Serum concentrations for Total antioxidants, total peroxides, peroxidase-activity, polyphenols and homocysteine.
Biometry:
Comparison of interventions in a cross-over approach descriptive and exploratory.
Group comparison: Parametric and non-parametric cross-over comparison Gaussian distribution - (Kolmogorov-Smirnov-test with Lilliefors-significances, alpha =10%).
Effect size: Two-sided 95%-confidence intervals
Analysis:
Intent-to-treat-analysis Per-protocol-analysis Full analysis set
Vitamin B and Homocysteine analysis was done in a routine laboratory. Antioxidants (TAC), peroxidase-activity (EPA), peroxides (TOC) and polyphenols (PPm) were measured by the use of commercially available microtitre assays at a wavelength of 450 vs. 620 nm. In case of PPm a wavelength of 766nm was used.
Implausible values will be scored as missing values. Missing values are not substituted.
Presentation of results:
Minimum-Median-Quartiles-Maximum-Mean-Standard deviation. Box Plots, Bar graph, tables.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8036
- Wonisch Willibald
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female
- 18-65 y
- Healthy
Exclusion Criteria:
- Cholesterol >240mg/dl
- Study inclusion in the past 2 months
- Pregnancy and lactation period
- Clinical diagnosis of chronic infections
- Ingestion of trace elements, vitamin- and fatty acid supplements in the past 3 months
- Clinical diagnosis of cardiovascular disease
- Clinical diagnosis of cancer
- Clinical diagnosis of psychotic diseases
- Insulin dependent diabetes
- Clinical diagnosis of autoimmune diseases
- Maldigestion/Malabsorption
- Veganes cuisine
- > 1 Beer/day
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Natural Panmol-B-Complex first, then synthetic Vitamin B-complex
Participants first received a Natural Vitamin B-complex, i.e., Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.
After a wash-out period of 2 weeks, they then received a synthetic Vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.The study finished after the second wash-out period for another 6 weeks.
|
Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) - Synthetic Vitamin B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg)
|
Active Comparator: Synthetic Vitamin B-complex first, then Natural Panmol-B-Complex
Participants first received a Synthetic Vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.
After a wash-out period of 2 weeks, they then received a natural Vitamin B-complex, i.e., Panmol-B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85µg) - Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Thiamine
Time Frame: 20 weeks
|
Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98
|
20 weeks
|
Serum Riboflavin
Time Frame: 20 weeks
|
Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341
|
20 weeks
|
Serum Pyridoxine
Time Frame: 20 weeks
|
Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8
|
20 weeks
|
Serum Folic Acid
Time Frame: 20 weeks
|
Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10
|
20 weeks
|
Serum Cobalamin
Time Frame: 20 weeks
|
Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Total Peroxides
Time Frame: 20 weeks
|
Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443
|
20 weeks
|
Serum Total Antioxidant Capacity
Time Frame: 20 weeks
|
Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45
|
20 weeks
|
Serum Endogenous Peroxidase-activity
Time Frame: 20 weeks
|
Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87
|
20 weeks
|
Serum Polyphenols
Time Frame: 20 weeks
|
Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91
|
20 weeks
|
Total Homocysteine
Time Frame: 20 weeks
|
Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40
|
20 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lindschinger M, Tatzber F, Schimetta W, Schmid I, Lindschinger B, Cvirn G, Stanger O, Lamont E, Wonisch W. A Randomized Pilot Trial to Evaluate the Bioavailability of Natural versus Synthetic Vitamin B Complexes in Healthy Humans and Their Effects on Homocysteine, Oxidative Stress, and Antioxidant Levels. Oxid Med Cell Longev. 2019 Dec 12;2019:6082613. doi: 10.1155/2019/6082613. eCollection 2019.
- Lindschinger M, Tatzber F, Schimetta W, Schmid I, Lindschinger B, Cvirn G, Fuchs N, Markolin G, Lamont E, Wonisch W. [Bioavailability of natural versus synthetic B vitamins and their effects on metabolic processes]. MMW Fortschr Med. 2020 Mar;162(Suppl 4):17-27. doi: 10.1007/s15006-020-0230-4. Epub 2020 Mar 19. German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medical University of Graz
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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