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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

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).

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Panmol-B-Complex Dietary Supplement: Synthetic Vitamin B-Complex Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Official Title: Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : November 17, 2017


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444155


Locations
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Austria
Wonisch Willibald
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz

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Responsible Party: Priv.-Doz. Mag. Dr. Willibald Wonisch, Principal Investigator, Medical University of Graz
ClinicalTrials.gov Identifier: NCT03444155     History of Changes
Other Study ID Numbers: Medical University of Graz
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia
Metabolic Diseases
Vitamin B 12 Deficiency
Folic Acid Deficiency
Vitamin B 6 Deficiency
Pellagra
Thiamine Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hematologic Diseases
Vitamins
Folic Acid
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics