Natural Versus Synthetic Vitamin B Complexes in Human

Healthy Clinical Trial

Official title:

Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444155
• Other study ID #: Medical University of Graz
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: November 17, 2017

Study information

• Verified date: April 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 17, 2017
• Est. primary completion date: October 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Folic Acid Deficiency
• Folic Acid Deficiency Anemia, Dietary
• Healthy
• Homocystine; Metabolic Disorder
• Metabolic Diseases
• Oxidative Stress
• Peroxidase; Defect
• Polyphenols
• Pyridoxine Deficiency
• Thiamine and Niacin Deficiency States
• Vitamin B 12 Deficiency
• Vitamin B 6 Deficiency

Intervention

Dietary Supplement:
• Natural 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)
• Synthetic 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)

Locations

Country	Name	City	State
Austria	Wonisch Willibald	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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) — View Citation

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 Homo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Thiamine	Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98	20 weeks
Primary	Serum Riboflavin	Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341	20 weeks
Primary	Serum Pyridoxine	Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8	20 weeks
Primary	Serum Folic Acid	Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10	20 weeks
Primary	Serum Cobalamin	Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230	20 weeks
Secondary	Serum Total Peroxides	Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443	20 weeks
Secondary	Serum Total Antioxidant Capacity	Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45	20 weeks
Secondary	Serum Endogenous Peroxidase-activity	Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87	20 weeks
Secondary	Serum Polyphenols	Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91	20 weeks
Secondary	Total Homocysteine	Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40	20 weeks