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In a cross-over study the investigators evaluate the effects of natural (Panmol-B-Complex) (Pan [Greek] = all; moles [Latin] = molecules/particles - brand name) versus synthetic vitamin B complexes to identify the bioavailability of distinct vitamins as well as long-term effects. The primary hypothesis for this study: "Natural Vitamin B-complexes are as effective as synthetic Vitamin B-complexes or better." For this reason 30 subjects (18 to 65y; BMI >19 to <29) were recruited for this study. The study population was divided into 2 groups of each 15 subjects in a cross-over trial. Vitamin supplementation consisted of Thiamine (2.93 mg), Riboflavin (3.98 mg), Niacin (29.85 mg), Pantothenic acid (10.95 mg), Pyridoxine (3.38 mg), Biotin (0.108 mg), Folic acid (0.69 mg) and Cobalamin (8.85 µg) per day in both groups. Blood samples are taken at baseline - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - wash out phase I (2 weeks); start cross-over: baseline - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - washout phase II (6 weeks). In case of main target criteria Thiamin, Riboflavin, Pyridoxine, Folic acid and Cobalamin were measured in serum as well as total peroxides (µmol/L), peroxidase-activity (U/L), total antioxidant status (mmol/L) and polyphenols (mmol/L).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Panmol-B-Complex first, then synthetic Vitamin B-complex | Active Comparator | 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. |
|
| Synthetic Vitamin B-complex first, then Natural Panmol-B-Complex | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Panmol-B-Complex | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Thiamine | Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98 | 20 weeks |
| Serum Riboflavin | Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341 | 20 weeks |
| Serum Pyridoxine | Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8 | 20 weeks |
| Serum Folic Acid | Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10 | 20 weeks |
| Serum Cobalamin | Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230 | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Peroxides | Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443 | 20 weeks |
| Serum Total Antioxidant Capacity | Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonisch Willibald | Graz | Styria | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31915511 | Result | 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. | |
| 32189314 |
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Of 36 enrolled participants, 30 met inclusion criteria and were randomized to treatment, i.e., to receive a natural (n=15) or synthetic vitamin B complex (n=15) after a 3 weeks run-in phase.
36 subjects were screened for eligibility at an Outpatient Clinic in Laßnitzhöhe, Styria, Austria
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| ID | Title | Description |
|---|---|---|
| FG000 | Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complex | Participants first received 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 (8.85µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received 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) each morning for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2017 |
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Vitamin B complex (natural vs. synthetic) administered in capsules each day for 6 weeks - 2 weeks wash-out phase I (2 weeks) - cross-over 6 weeks - wash-out phase II (6 weeks)
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Masking was organized and supervised by the randomization person in charge. Group assignment was 1:1 (control vs. verum group) with identical packages for both Vitamin supplements with 126 capsules for each subject per phase. Randomization was done with sealed envelopes.
|
| Synthetic Vitamin B-Complex | Dietary Supplement | 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) |
|
| 20 weeks |
| Serum Endogenous Peroxidase-activity | Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87 | 20 weeks |
| Serum Polyphenols | Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91 | 20 weeks |
| Total Homocysteine | Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40 | 20 weeks |
| Result |
| 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. |
| FG001 | Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex | Participants first received 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) each morning for 6 weeks. After a washout period of 2 weeks, they then received 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) each morning for 6 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout (2 Weeks) |
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| Second Intervention (6 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 (3.38mg), 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. |
| BG001 | Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex | Participants first received a synthetic vitamin B complex i.e. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Thiamine | Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98 | Posted | Mean | Standard Deviation | "µg/L" | 20 weeks |
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| Primary | Serum Riboflavin | Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341 | Posted | Mean | Standard Deviation | "µg/L" | 20 weeks |
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| Primary | Serum Pyridoxine | Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8 | Posted | Mean | Standard Deviation | "µg/L" | 20 weeks |
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| Primary | Serum Folic Acid | Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10 | Posted | Mean | Standard Deviation | "ng/L" | 20 weeks |
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| Primary | Serum Cobalamin | Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230 | Posted | Mean | Standard Deviation | "pg/L" | 20 weeks |
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| Secondary | Serum Total Peroxides | Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443 | Posted | Mean | Standard Deviation | "µM/L" | 20 weeks |
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| Secondary | Serum Total Antioxidant Capacity | Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45 | Posted | Mean | Standard Deviation | "mM/L" | 20 weeks |
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| Secondary | Serum Endogenous Peroxidase-activity | Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87 | Posted | Mean | Standard Deviation | "mU/mL" | 20 weeks |
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| Secondary | Serum Polyphenols | Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91 | Posted | Mean | Standard Deviation | "mM/L" | 20 weeks |
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| Secondary | Total Homocysteine | Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40 | Posted | Mean | Standard Deviation | "µM" | 20 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Natural Panmol-B-Complex | Participants received a 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) daily each morning for 6 weeks. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG001 | Synthetic Vitamin-B-Complex | Participants received a Synthetic Vitamin-B-Complex consisting of - 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 (matching the Natural Panmol-B-Complex). | 0 | 30 | 0 | 30 | 0 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flush | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Willibald Wonisch | Otto Loewi Research Center, Chair of Physiological Medicine, Medical University of Graz, Austria | 00436505299540 | willibald.wonisch@medunigraz.at |
| Feb 13, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D026681 | Vitamin B 6 Deficiency |
| D014806 | Vitamin B 12 Deficiency |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Race (NIH/OMB) |
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| 4 hours |
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| 7 hours |
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| 6 weeks |
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| 8 weeks |
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| 8 weeks - 1.5 hours |
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| 8 weeks - 4 hours |
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| 8 weeks - 7 hours |
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| 14 weeks |
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| 20 weeks |
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