N/A
N=30
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
Bottom Line
View on ClinicalTrials.gov: NCT03444155 ↗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
| Outcome | Result | p-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
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.