Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03444155
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2018-01-08
Brief Title:
Natural Versus Synthetic Vitamin B Complexes in Human
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a cross-over study the investigators evaluate the effects of natural Panmol-B-Complex Pan Greek all moles Latin moleculesparticles - 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 293 mg Riboflavin 398 mg Niacin 2985 mg Pantothenic acid 1095 mg Pyridoxine 338 mg Biotin 0108 mg Folic acid 069 mg and Cobalamin 885 µg per day in both groups Blood samples are taken at baseline - 15h after vitamin supplementation - 4h - 7h - 6 weeks - wash out phase I 2 weeks start cross-over baseline - 15h 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 µmolL peroxidase-activity UL total antioxidant status mmolL and polyphenols mmolL
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
BlindingRandomization
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 11 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 15 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 15 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
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
BlindingRandomization
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 11 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 15 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 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None