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CompletedNCT03444155Updated Apr 26, 2021Results posted

Natural Versus Synthetic Vitamin B Complexes in Human

An interventional study of Natural Panmol-B-Complex and Synthetic Vitamin B-Complex in Healthy, Thiamine and Niacin Deficiency States and Pyridoxine Deficiency, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy
  • Thiamine and Niacin Deficiency States
  • Pyridoxine Deficiency
  • Folic Acid Deficiency Anemia, Dietary
  • Vitamin B 12 Deficiency
  • Peroxidase; Defect
  • Polyphenols
  • Oxidative Stress
  • Homocystine; Metabolic Disorder
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female
  • 18-65 y
  • Healthy

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Dietary Supplement: Natural Panmol-B-Complex

  • 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.

    Dietary Supplement: Synthetic Vitamin B-Complex

Interventions

  • Dietary supplementNatural Panmol-B-Complex

    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)

  • Dietary supplementSynthetic Vitamin B-Complex

    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)

05

What researchers measure

Primary outcomes

  1. Serum Thiamine

    Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98

    Time frame: 20 weeks

  2. Serum Riboflavin

    Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341

    Time frame: 20 weeks

  3. Serum Pyridoxine

    Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8

    Time frame: 20 weeks

  4. Serum Folic Acid

    Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10

    Time frame: 20 weeks

  5. Serum Cobalamin

    Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230

    Time frame: 20 weeks

Secondary outcomes

  1. Serum Total Peroxides

    Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443

    Time frame: 20 weeks

  2. Serum Total Antioxidant Capacity

    Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45

    Time frame: 20 weeks

  3. Serum Endogenous Peroxidase-activity

    Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87

    Time frame: 20 weeks

  4. Serum Polyphenols

    Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91

    Time frame: 20 weeks

  5. Total Homocysteine

    Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40

    Time frame: 20 weeks

06

Results

Posted Apr 26, 2021

Participant flow

36 subjects were screened for eligibility at an Outpatient Clinic in Laßnitzhöhe, Styria, Austria

First Intervention (6 Weeks)
Participant flow — First Intervention (6 Weeks)
MilestoneNatural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-Complex
Started1515
Completed1415
Not completed10
Withdrew: Adverse event10
Washout (2 Weeks)
Participant flow — Washout (2 Weeks)
MilestoneNatural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-Complex
Started1415
Completed1415
Not completed00
Second Intervention (6 Weeks)
Participant flow — Second Intervention (6 Weeks)
MilestoneNatural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-Complex
Started1415
Completed1415
Not completed00

Outcome measures

PrimarySerum Thiamine

Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98

Time frame:
20 weeks
Reported as:
Mean · "µg/L"
Serum Thiamine
"µg/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline50.21 ± 8.0748.33 ± 6.51
1.5 hours51.21 ± 8.1150.60 ± 8.72
4 hours53.57 ± 7.4551.07 ± 7.20
7 hours52.00 ± 7.0650.27 ± 8.74
6 weeks61.86 ± 9.8161.33 ± 9.39
8 weeks70.14 ± 12.0472.33 ± 10.75
8 weeks - 1.5 hours70.21 ± 8.9469.13 ± 9.77
8 weeks - 4 hours64.71 ± 8.9165.13 ± 10.95
8 weeks - 7 hours64.64 ± 8.1464.20 ± 7.27
14 weeks58.86 ± 10.5061.60 ± 9.91
20 weeks58.43 ± 10.5259.20 ± 9.70
PrimarySerum Riboflavin

Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341

Time frame:
20 weeks
Reported as:
Mean · "µg/L"
Serum Riboflavin
"µg/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline231.93 ± 10.97234.67 ± 21.87
1.5 hours233.86 ± 17.91245.60 ± 21.88
4 hours240.36 ± 18.14254.33 ± 27.63
7 hours247.21 ± 20.08252.87 ± 27.03
6 weeks264.21 ± 17.62265.00 ± 28.83
8 weeks232.29 ± 13.29238.73 ± 14.18
8 weeks - 1.5 hours230.43 ± 9.72233.27 ± 21.63
8 weeks - 4 hours237.36 ± 13.11243.20 ± 15.42
8 weeks - 7 hours244.64 ± 8.11250.13 ± 14.71
14 weeks258.14 ± 15.68271.07 ± 20.66
20 weeks257.93 ± 12.75274.67 ± 28.30
PrimarySerum Pyridoxine

Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8

Time frame:
20 weeks
Reported as:
Mean · "µg/L"
Serum Pyridoxine
"µg/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline23.11 ± 13.1824.31 ± 25.80
1.5 hours35.45 ± 20.6433.80 ± 29.23
4 hours32.96 ± 17.9533.28 ± 28.81
7 hours36.66 ± 21.8936.59 ± 25.83
6 weeks46.44 ± 20.1048.94 ± 39.41
8 weeks29.23 ± 26.9926.99 ± 33.38
8 weeks - 1.5 hours33.79 ± 20.7136.93 ± 36.49
8 weeks - 4 hours39.14 ± 28.2035.76 ± 32.58
8 weeks - 7 hours42.93 ± 27.3540.41 ± 39.87
14 weeks42.24 ± 20.6439.97 ± 26.30
20 weeks28.38 ± 26.2621.39 ± 26.69
PrimarySerum Folic Acid

Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10

Time frame:
20 weeks
Reported as:
Mean · "ng/L"
Serum Folic Acid
"ng/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline7.45 ± 3.296.00 ± 2.79
1.5 hours25.21 ± 10.1720.75 ± 8.32
4 hours12.87 ± 4.6710.93 ± 2.96
7 hours10.38 ± 3.548.23 ± 2.62
6 weeks13.86 ± 2.7715.18 ± 4.96
8 weeks11.04 ± 2.8010.43 ± 3.04
8 weeks - 1.5 hours26.63 ± 10.5231.87 ± 14.51
8 weeks - 4 hours16.39 ± 6.8214.43 ± 2.29
8 weeks - 7 hours12.63 ± 2.4812.19 ± 2.10
14 weeks18.59 ± 11.6418.70 ± 14.42
20 weeks10.46 ± 2.339.93 ± 3.36
PrimarySerum Cobalamin

Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230

Time frame:
20 weeks
Reported as:
Mean · "pg/L"
Serum Cobalamin
"pg/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline381.71 ± 112.73440.47 ± 246.82
1.5 hours387.79 ± 122.48453.67 ± 235.70
4 hours384.50 ± 105.92447.00 ± 210.03
7 hours388.57 ± 116.72442.27 ± 213.16
6 weeks442.36 ± 142.74506.47 ± 166.44
8 weeks414.79 ± 125.67450.33 ± 143.61
8 weeks - 1.5 hours414.57 ± 132.69454.07 ± 141.05
8 weeks - 4 hours389.21 ± 115.06432.07 ± 131.89
8 weeks - 7 hours404.93 ± 111.60453.13 ± 129.37
14 weeks483.57 ± 139.02564.27 ± 170.41
20 weeks421.07 ± 134.95494.80 ± 176.79
SecondarySerum Total Peroxides

Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443

Time frame:
20 weeks
Reported as:
Mean · "µM/L"
Serum Total Peroxides
"µM/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline100.00 ± 46.17111.17 ± 96.01
1.5 hours101.64 ± 38.65112.67 ± 88.23
4 hours132.55 ± 43.72137.08 ± 95.05
7 hours122.18 ± 46.42132.75 ± 108.81
6 weeks97.36 ± 39.6999.58 ± 31.84
8 weeks79.27 ± 25.8671.25 ± 25.69
8 weeks - 1.5 hours97.27 ± 22.3686.92 ± 25.04
8 weeks - 4 hours99.91 ± 23.2892.50 ± 24.99
8 weeks - 7 hours89.18 ± 20.0490.17 ± 27.33
14 weeks102.91 ± 23.78115.83 ± 64.46
20 weeks104.91 ± 39.91116.33 ± 105.86
SecondarySerum Total Antioxidant Capacity

Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45

Time frame:
20 weeks
Reported as:
Mean · "mM/L"
Serum Total Antioxidant Capacity
"mM/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline1.15 ± 0.431.45 ± 0.23
1.5 hours1.27 ± 0.311.24 ± 0.24
4 hours1.13 ± 0.331.23 ± 0.34
7 hours1.22 ± 0.441.39 ± 0.40
6 weeks1.45 ± 0.381.54 ± 0.22
8 weeks1.20 ± 0.221.31 ± 0.29
8 weeks - 1.5 hours1.68 ± 0.521.86 ± 0.30
8 weeks - 4 hours1.14 ± 0.381.30 ± 0.34
8 weeks - 7 hours1.38 ± 0.321.18 ± 0.57
14 weeks1.46 ± 0.321.48 ± 0.33
20 weeks1.34 ± 0.281.47 ± 0.38
SecondarySerum Endogenous Peroxidase-activity

Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87

Time frame:
20 weeks
Reported as:
Mean · "mU/mL"
Serum Endogenous Peroxidase-activity
"mU/mL"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline3.37 ± 1.743.07 ± 1.09
1.5 hours3.35 ± 1.493.90 ± 2.03
4 hours4.37 ± 1.264.22 ± 1.03
7 hours5.31 ± 1.134.84 ± 0.93
6 weeks4.36 ± 0.834.34 ± 0.55
8 weeks6.05 ± 1.825.15 ± 1.24
8 weeks - 1.5 hours3.97 ± 1.623.60 ± 1.03
8 weeks - 4 hours3.99 ± 1.123.93 ± 1.41
8 weeks - 7 hours4.35 ± 1.305.48 ± 1.74
14 weeks3.89 ± 1.534.95 ± 2.01
20 weeks3.04 ± 1.342.96 ± 1.14
SecondarySerum Polyphenols

Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91

Time frame:
20 weeks
Reported as:
Mean · "mM/L"
Serum Polyphenols
"mM/L"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline9.88 ± 0.349.57 ± 0.34
1.5 hours9.73 ± 0.459.77 ± 0.67
4 hours9.97 ± 0.389.81 ± 0.45
7 hours9.72 ± 0.319.54 ± 0.43
6 weeks9.49 ± 0.359.46 ± 0.41
8 weeks9.73 ± 0.299.54 ± 0.53
8 weeks - 1.5 hours8.87 ± 0.668.71 ± 0.42
8 weeks - 4 hours8.25 ± 0.708.18 ± 0.70
8 weeks - 7 hours8.68 ± 0.358.57 ± 0.40
14 weeks8.72 ± 0.528.82 ± 0.44
20 weeks9.67 ± 0.349.46 ± 0.64
SecondaryTotal Homocysteine

Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40

Time frame:
20 weeks
Reported as:
Mean · "µM"
Total Homocysteine
"µM"Panmol-B-ComplexSynthetic Vitamin B-complex
Baseline8.89 ± 1.9911.49 ± 7.57
1.5 hours8.96 ± 2.3211.89 ± 8.20
4 hours8.68 ± 1.9811.38 ± 8.01
7 hours8.91 ± 2.0311.31 ± 7.89
6 weeks7.76 ± 1.437.85 ± 1.89
8 weeks7.89 ± 1.588.16 ± 1.58
8 weeks - 1.5 hours7.91 ± 1.477.97 ± 1.45
8 weeks - 4 hours7.34 ± 1.457.39 ± 1.31
8 weeks - 7 hours8.00 ± 1.708.13 ± 1.69
14 weeks7.01 ± 1.597.44 ± 1.55
20 weeks7.62 ± 2.037.95 ± 1.88

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Natural Panmol-B-Complex0/30 (0%)0/30 (0%)1/30 (3.3%)
Synthetic Vitamin-B-Complex0/30 (0%)0/30 (0%)0/30 (0%)
Most frequent other events
Most frequent other events
EventNatural Panmol-B-ComplexSynthetic Vitamin-B-Complex
FlushSkin and subcutaneous tissue disorders1/300/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-ComplexTotal
<=18 years000
Between 18 and 65 years141529
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-ComplexTotal
Female111021
Male358
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-ComplexTotal
Ethnicity (NIH/OMB) — Hispanic or Latino000
Ethnicity (NIH/OMB) — Not Hispanic or Latino141529
Ethnicity (NIH/OMB) — Unknown or Not Reported000
Race (NIH/OMB) — Hispanic or Latino000
Race (NIH/OMB) — Not Hispanic or Latino141529
Race (NIH/OMB) — Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complexSynthetic Vitamin B-complex First, Then Natural Panmol-B-ComplexTotal
Austria141529
07

Study locations

1 site
  • Wonisch Willibald
    Graz, Styria 8036, Austria
08

References and documents

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 31915511 ↗
  • 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. PubMed 32189314 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 13, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03444155
Lead sponsor
Medical University of Graz
Responsible party
Priv.-Doz. Mag. Dr. Willibald Wonisch (Principal Investigator, Medical University of Graz) — Principal investigator
First posted
Feb 23, 2018
Start date
May 8, 2017
Primary completion
Oct 3, 2017
Completion
Nov 17, 2017
Results posted
Apr 26, 2021
Last update
Apr 26, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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