HealthyNCT03444155
Natural Versus Synthetic Vitamin B Complexes in Human
A study testing Natural Panmol-B-Complex and Synthetic Vitamin B-Complex in people with Healthy and Thiamine and Niacin Deficiency States, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Thiamine and Niacin Deficiency States, Pyridoxine Deficiency
- What is being tested?
- Natural Panmol-B-Complex and Synthetic Vitamin B-Complex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 8 May 2017to 17 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female
- 18-65 y
- Healthy
Who cannot join
- 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
Show all 13Show fewer
- Clinical diagnosis of cancer
- Clinical diagnosis of psychotic diseases
- Insulin dependent diabetes
- Clinical diagnosis of autoimmune diseases
- Maldigestion/Malabsorption
- Veganes cuisine
- > 1 Beer/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.
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).
Read the 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.
- Conditions
- Healthy, Thiamine and Niacin Deficiency States, Pyridoxine Deficiency, Folic Acid Deficiency Anemia, Dietary, Vitamin B 12 Deficiency, Peroxidase; Defect
- Being tested
- Natural Panmol-B-Complex, Synthetic Vitamin B-Complex
- Medical subject headings
- Vitamin B 6 Deficiency, Vitamin B 12 Deficiency, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Panmol-B-ComplexDietary 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)
Synthetic Vitamin B-ComplexDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Natural Panmol-B-Complex |
| 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. Receives: Dietary Supplement: Synthetic Vitamin B-Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Thiamine
Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98
Measured: 20 weeks
Serum Riboflavin
Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341
Measured: 20 weeks
Serum Pyridoxine
Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8
Measured: 20 weeks
Serum Folic Acid
Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10
Measured: 20 weeks
Serum Cobalamin
Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230
Measured: 20 weeks
Secondary outcomes (5)
Serum Total Peroxides
Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443
Measured: 20 weeks
Serum Total Antioxidant Capacity
Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45
Measured: 20 weeks
Serum Endogenous Peroxidase-activity
Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87
Measured: 20 weeks
Serum Polyphenols
Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91
Measured: 20 weeks
Total Homocysteine
Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start8 May 2017
- Primary completion3 Oct 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priv.-Doz. Mag. Dr. Willibald Wonisch, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444155
- Sponsor's protocol ID
- Medical University of Graz
- Status last verified
- Apr 2021
- First submitted
- 8 Jan 2018
- Last updated
- 26 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31915511Lindschinger 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.
PubMed 32189314
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.
- ClinicalTrials.gov ID
- NCT03444155
- Acronym / sponsor ID
- Medical University of Graz
- Conditions
- Healthy, Thiamine and Niacin Deficiency States, Pyridoxine Deficiency, Folic Acid Deficiency Anemia, Dietary, Vitamin B 12 Deficiency, Peroxidase; Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Natural Panmol-B-Complex first, then synthetic Vitamin B-complex | Active comparator | Dietary Supplement: Natural Panmol-B-ComplexParticipants 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 | Dietary Supplement: Synthetic Vitamin B-ComplexParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female
- 18-65 y
- Healthy
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Panmol-B-ComplexNatural 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) | Dietary supplement | Natural Panmol-B-Complex first, then synthetic Vitamin B-complex |
| Synthetic Vitamin B-ComplexSynthetic 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) | Dietary supplement | Synthetic Vitamin B-complex first, then Natural Panmol-B-Complex |
Primary outcome
Serum Thiamine
Time frame: 20 weeks
Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98
Serum Riboflavin
Time frame: 20 weeks
Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341
Serum Pyridoxine
Time frame: 20 weeks
Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8
Serum Folic Acid
Time frame: 20 weeks
Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10
Serum Cobalamin
Time frame: 20 weeks
Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230
5 secondary outcomes
Serum Total Peroxides
Time frame: 20 weeks
Serum Total Antioxidant Capacity
Time frame: 20 weeks
Serum Endogenous Peroxidase-activity
Time frame: 20 weeks
Serum Polyphenols
Time frame: 20 weeks
Total Homocysteine
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31915511Lindschinger 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.
- Results publication: PubMed 32189314Lindschinger 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.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Panmol-B-Complex and Synthetic Vitamin B-Complex in people with Healthy and Thiamine and Niacin Deficiency States, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Thiamine (time frame: 20 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444155, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.