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Natural Versus Synthetic Vitamin B Complexes in Human

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ClinicalTrials.gov Identifier: NCT03444155
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Priv.-Doz. Mag. Dr. Willibald Wonisch, Medical University of Graz

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date April 17, 2018
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date October 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2018)
  • Serum Thiamine in µg/L [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statistical significant.
  • Serum Riboflavin in µg/L [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statistical significant.
  • Serum Pyridoxine in µg/L [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statistical significant.
  • Serum Folic acid in ng/mL [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statistical significant.
  • Serum Cobalamin in pg/mL [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statistical significant.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2018)
  • Serum Total peroxides in µmol/L [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statitical significant.
  • Serum Total antioxidant capacity in mmol/L [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statitical significant.
  • Serum Endogenous peroxidase-activity in mU/mL [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statitical significant.
  • Serum Polyphenols in mmol/L [ Time Frame: 18 weeks ]
    A difference of p<0.05 between groups and time-points will be assessed as statitical significant.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Natural Versus Synthetic Vitamin B Complexes in Human
Official Title  ICMJE Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.
Brief Summary In a cross-over study the investigators evaluate the effects of natural (Panmol-B-Complex) 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 (2,77mg), Riboflavin (3,53mg), Niacin (40,32mg), Pantothenic acid (15,12mg), Pyridoxine (3,53mg), Biotin (0,13mg), Folic acid (0,50mg) and Cobalamin (6,3µg) 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 capsules coated with gelatine (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 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 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 homocystein.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator)
Masking Description:
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.
Primary Purpose: Basic Science
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Dietary Supplement: Panmol-B-Complex
    B1 (2,77mg), B2 (3,53mg), B3 (40,32mg), B5 (15,12mg), B6 (3,53mg), B7 (0,13mg), B9 (0,50mg), B12 (6,3µg) daily for 6 weeks.
  • Dietary Supplement: Synthetic Vitamin B-Complex
    B1 (2,77mg), B2 (3,53mg), B3 (40,32mg), B5 (15,12mg), B6 (3,53mg), B7 (0,13mg), B9 (0,50mg), B12 (6,3µg) daily for 6 weeks.
Study Arms  ICMJE
  • Active Comparator: Panmol-B-Complex
    B1 (2,77mg), B2 (3,53mg), B3 (40,32mg), B5 (15,12mg), B6 (3,53mg), B7 (0,13mg), B9 (0,50mg), B12 (6,3µg) daily for 6 weeks.
    Intervention: Dietary Supplement: Panmol-B-Complex
  • Active Comparator: Synthetic Vitamin B-complex
    B1 (2,77mg), B2 (3,53mg), B3 (40,32mg), B5 (15,12mg), B6 (3,53mg), B7 (0,13mg), B9 (0,50mg), B12 (6,3µg) daily for 6 weeks.
    Intervention: Dietary Supplement: Synthetic Vitamin B-Complex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 17, 2017
Actual Primary Completion Date October 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03444155
Other Study ID Numbers  ICMJE Medical University of Graz
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Priv.-Doz. Mag. Dr. Willibald Wonisch, Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Graz
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP