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N/A N=30 Randomized Double-blind Basic Science

Natural Versus Synthetic Vitamin B Complexes in Human

Healthy · Thiamine and Niacin Deficiency States · Pyridoxine Deficiency · Folic Acid Deficiency Anemia, Dietary · Vitamin B 12 Deficiency

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Serum Thiamine — 50.21; 48.33; 51.21; 50.60 "µg/L"

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Natural Panmol-B-Complex (Dietary_supplement); Synthetic Vitamin B-Complex (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medical University of Graz
Primary completion
Oct 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Serum Thiamine
50.21; 48.33; 51.21; 50.60; 53.57; 51.07
PRIMARY
Serum Riboflavin
231.93; 234.67; 233.86; 245.60; 240.36; 254.33
PRIMARY
Serum Pyridoxine
23.11; 24.31; 35.45; 33.80; 32.96; 33.28
PRIMARY
Serum Folic Acid
7.45; 6.00; 25.21; 20.75; 12.87; 10.93
PRIMARY
Serum Cobalamin
381.71; 440.47; 387.79; 453.67; 384.50; 447.00
SECONDARY
Serum Total Peroxides
100.00; 111.17; 101.64; 112.67; 132.55; 137.08
SECONDARY
Serum Total Antioxidant Capacity
1.15; 1.45; 1.27; 1.24; 1.13; 1.23
SECONDARY
Serum Endogenous Peroxidase-activity
3.37; 3.07; 3.35; 3.90; 4.37; 4.22
SECONDARY
Serum Polyphenols
9.88; 9.57; 9.73; 9.77; 9.97; 9.81
SECONDARY
Total Homocysteine
8.89; 11.49; 8.96; 11.89; 8.68; 11.38

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).

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03444155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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