Trial Outcomes & Findings for Natural Versus Synthetic Vitamin B Complexes in Human (NCT NCT03444155)
NCT ID: NCT03444155
Last Updated: 2021-04-26
Results Overview
Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
20 weeks
Results posted on
2021-04-26
Participant Flow
36 subjects were screened for eligibility at an Outpatient Clinic in Laßnitzhöhe, Styria, Austria
Of 36 enrolled participants, 30 met inclusion criteria and were randomized to treatment, i.e., to receive a natural (n=15) or synthetic vitamin B complex (n=15) after a 3 weeks run-in phase.
Participant milestones
| Measure |
Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complex
Participants first received Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received Synthetic Vitamin B-complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks.
|
Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex
Participants first received Synthetic Vitamin B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks.
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
15
|
15
|
|
First Intervention (6 Weeks)
COMPLETED
|
14
|
15
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Washout (2 Weeks)
STARTED
|
14
|
15
|
|
Washout (2 Weeks)
COMPLETED
|
14
|
15
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
14
|
15
|
|
Second Intervention (6 Weeks)
COMPLETED
|
14
|
15
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complex
Participants first received Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received Synthetic Vitamin B-complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks.
|
Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex
Participants first received Synthetic Vitamin B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks. After a washout period of 2 weeks, they then received Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) each morning for 6 weeks.
|
|---|---|---|
|
First Intervention (6 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Natural Versus Synthetic Vitamin B Complexes in Human
Baseline characteristics by cohort
| Measure |
Natural Panmol-B-Complex First, Then Synthetic Vitamin B-complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex First, Then Natural Panmol-B-Complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB) · Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB) · Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB) · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Race (NIH/OMB) · Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Race (NIH/OMB) · Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Race (NIH/OMB) · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 20 weeksSerum Thiamine in microgram per liter Minimum: 36 Maximum: 98
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Thiamine
Baseline
|
50.21 "µg/L"
Standard Deviation 8.07
|
48.33 "µg/L"
Standard Deviation 6.51
|
|
Serum Thiamine
1.5 hours
|
51.21 "µg/L"
Standard Deviation 8.11
|
50.60 "µg/L"
Standard Deviation 8.72
|
|
Serum Thiamine
4 hours
|
53.57 "µg/L"
Standard Deviation 7.45
|
51.07 "µg/L"
Standard Deviation 7.20
|
|
Serum Thiamine
7 hours
|
52.00 "µg/L"
Standard Deviation 7.06
|
50.27 "µg/L"
Standard Deviation 8.74
|
|
Serum Thiamine
6 weeks
|
61.86 "µg/L"
Standard Deviation 9.81
|
61.33 "µg/L"
Standard Deviation 9.39
|
|
Serum Thiamine
8 weeks
|
70.14 "µg/L"
Standard Deviation 12.04
|
72.33 "µg/L"
Standard Deviation 10.75
|
|
Serum Thiamine
8 weeks - 1.5 hours
|
70.21 "µg/L"
Standard Deviation 8.94
|
69.13 "µg/L"
Standard Deviation 9.77
|
|
Serum Thiamine
8 weeks - 4 hours
|
64.71 "µg/L"
Standard Deviation 8.91
|
65.13 "µg/L"
Standard Deviation 10.95
|
|
Serum Thiamine
8 weeks - 7 hours
|
64.64 "µg/L"
Standard Deviation 8.14
|
64.20 "µg/L"
Standard Deviation 7.27
|
|
Serum Thiamine
14 weeks
|
58.86 "µg/L"
Standard Deviation 10.50
|
61.60 "µg/L"
Standard Deviation 9.91
|
|
Serum Thiamine
20 weeks
|
58.43 "µg/L"
Standard Deviation 10.52
|
59.20 "µg/L"
Standard Deviation 9.70
|
PRIMARY outcome
Timeframe: 20 weeksSerum Riboflavin in microgram per liter Minimum: 190 Maximum: 341
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Riboflavin
4 hours
|
240.36 "µg/L"
Standard Deviation 18.14
|
254.33 "µg/L"
Standard Deviation 27.63
|
|
Serum Riboflavin
Baseline
|
231.93 "µg/L"
Standard Deviation 10.97
|
234.67 "µg/L"
Standard Deviation 21.87
|
|
Serum Riboflavin
1.5 hours
|
233.86 "µg/L"
Standard Deviation 17.91
|
245.60 "µg/L"
Standard Deviation 21.88
|
|
Serum Riboflavin
7 hours
|
247.21 "µg/L"
Standard Deviation 20.08
|
252.87 "µg/L"
Standard Deviation 27.03
|
|
Serum Riboflavin
6 weeks
|
264.21 "µg/L"
Standard Deviation 17.62
|
265.00 "µg/L"
Standard Deviation 28.83
|
|
Serum Riboflavin
8 weeks
|
232.29 "µg/L"
Standard Deviation 13.29
|
238.73 "µg/L"
Standard Deviation 14.18
|
|
Serum Riboflavin
8 weeks - 1.5 hours
|
230.43 "µg/L"
Standard Deviation 9.72
|
233.27 "µg/L"
Standard Deviation 21.63
|
|
Serum Riboflavin
8 weeks - 4 hours
|
237.36 "µg/L"
Standard Deviation 13.11
|
243.20 "µg/L"
Standard Deviation 15.42
|
|
Serum Riboflavin
8 weeks - 7 hours
|
244.64 "µg/L"
Standard Deviation 8.11
|
250.13 "µg/L"
Standard Deviation 14.71
|
|
Serum Riboflavin
14 weeks
|
258.14 "µg/L"
Standard Deviation 15.68
|
271.07 "µg/L"
Standard Deviation 20.66
|
|
Serum Riboflavin
20 weeks
|
257.93 "µg/L"
Standard Deviation 12.75
|
274.67 "µg/L"
Standard Deviation 28.30
|
PRIMARY outcome
Timeframe: 20 weeksSerum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Pyridoxine
7 hours
|
36.66 "µg/L"
Standard Deviation 21.89
|
36.59 "µg/L"
Standard Deviation 25.83
|
|
Serum Pyridoxine
6 weeks
|
46.44 "µg/L"
Standard Deviation 20.10
|
48.94 "µg/L"
Standard Deviation 39.41
|
|
Serum Pyridoxine
8 weeks
|
29.23 "µg/L"
Standard Deviation 26.99
|
26.99 "µg/L"
Standard Deviation 33.38
|
|
Serum Pyridoxine
Baseline
|
23.11 "µg/L"
Standard Deviation 13.18
|
24.31 "µg/L"
Standard Deviation 25.80
|
|
Serum Pyridoxine
1.5 hours
|
35.45 "µg/L"
Standard Deviation 20.64
|
33.80 "µg/L"
Standard Deviation 29.23
|
|
Serum Pyridoxine
4 hours
|
32.96 "µg/L"
Standard Deviation 17.95
|
33.28 "µg/L"
Standard Deviation 28.81
|
|
Serum Pyridoxine
8 weeks - 1.5 hours
|
33.79 "µg/L"
Standard Deviation 20.71
|
36.93 "µg/L"
Standard Deviation 36.49
|
|
Serum Pyridoxine
8 weeks - 4 hours
|
39.14 "µg/L"
Standard Deviation 28.20
|
35.76 "µg/L"
Standard Deviation 32.58
|
|
Serum Pyridoxine
8 weeks - 7 hours
|
42.93 "µg/L"
Standard Deviation 27.35
|
40.41 "µg/L"
Standard Deviation 39.87
|
|
Serum Pyridoxine
14 weeks
|
42.24 "µg/L"
Standard Deviation 20.64
|
39.97 "µg/L"
Standard Deviation 26.30
|
|
Serum Pyridoxine
20 weeks
|
28.38 "µg/L"
Standard Deviation 26.26
|
21.39 "µg/L"
Standard Deviation 26.69
|
PRIMARY outcome
Timeframe: 20 weeksSerum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Folic Acid
8 weeks - 1.5 hours
|
26.63 "ng/L"
Standard Deviation 10.52
|
31.87 "ng/L"
Standard Deviation 14.51
|
|
Serum Folic Acid
8 weeks - 4 hours
|
16.39 "ng/L"
Standard Deviation 6.82
|
14.43 "ng/L"
Standard Deviation 2.29
|
|
Serum Folic Acid
8 weeks - 7 hours
|
12.63 "ng/L"
Standard Deviation 2.48
|
12.19 "ng/L"
Standard Deviation 2.10
|
|
Serum Folic Acid
Baseline
|
7.45 "ng/L"
Standard Deviation 3.29
|
6.00 "ng/L"
Standard Deviation 2.79
|
|
Serum Folic Acid
1.5 hours
|
25.21 "ng/L"
Standard Deviation 10.17
|
20.75 "ng/L"
Standard Deviation 8.32
|
|
Serum Folic Acid
4 hours
|
12.87 "ng/L"
Standard Deviation 4.67
|
10.93 "ng/L"
Standard Deviation 2.96
|
|
Serum Folic Acid
14 weeks
|
18.59 "ng/L"
Standard Deviation 11.64
|
18.70 "ng/L"
Standard Deviation 14.42
|
|
Serum Folic Acid
20 weeks
|
10.46 "ng/L"
Standard Deviation 2.33
|
9.93 "ng/L"
Standard Deviation 3.36
|
|
Serum Folic Acid
7 hours
|
10.38 "ng/L"
Standard Deviation 3.54
|
8.23 "ng/L"
Standard Deviation 2.62
|
|
Serum Folic Acid
6 weeks
|
13.86 "ng/L"
Standard Deviation 2.77
|
15.18 "ng/L"
Standard Deviation 4.96
|
|
Serum Folic Acid
8 weeks
|
11.04 "ng/L"
Standard Deviation 2.80
|
10.43 "ng/L"
Standard Deviation 3.04
|
PRIMARY outcome
Timeframe: 20 weeksSerum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Cobalamin
Baseline
|
381.71 "pg/L"
Standard Deviation 112.73
|
440.47 "pg/L"
Standard Deviation 246.82
|
|
Serum Cobalamin
1.5 hours
|
387.79 "pg/L"
Standard Deviation 122.48
|
453.67 "pg/L"
Standard Deviation 235.70
|
|
Serum Cobalamin
4 hours
|
384.50 "pg/L"
Standard Deviation 105.92
|
447.00 "pg/L"
Standard Deviation 210.03
|
|
Serum Cobalamin
7 hours
|
388.57 "pg/L"
Standard Deviation 116.72
|
442.27 "pg/L"
Standard Deviation 213.16
|
|
Serum Cobalamin
6 weeks
|
442.36 "pg/L"
Standard Deviation 142.74
|
506.47 "pg/L"
Standard Deviation 166.44
|
|
Serum Cobalamin
8 weeks
|
414.79 "pg/L"
Standard Deviation 125.67
|
450.33 "pg/L"
Standard Deviation 143.61
|
|
Serum Cobalamin
8 weeks - 1.5 hours
|
414.57 "pg/L"
Standard Deviation 132.69
|
454.07 "pg/L"
Standard Deviation 141.05
|
|
Serum Cobalamin
8 weeks - 4 hours
|
389.21 "pg/L"
Standard Deviation 115.06
|
432.07 "pg/L"
Standard Deviation 131.89
|
|
Serum Cobalamin
8 weeks - 7 hours
|
404.93 "pg/L"
Standard Deviation 111.60
|
453.13 "pg/L"
Standard Deviation 129.37
|
|
Serum Cobalamin
14 weeks
|
483.57 "pg/L"
Standard Deviation 139.02
|
564.27 "pg/L"
Standard Deviation 170.41
|
|
Serum Cobalamin
20 weeks
|
421.07 "pg/L"
Standard Deviation 134.95
|
494.80 "pg/L"
Standard Deviation 176.79
|
SECONDARY outcome
Timeframe: 20 weeksSerum Total peroxides in micromol per liter Minimum: 23 Maximum: 443
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Total Peroxides
Baseline
|
100.00 "µM/L"
Standard Deviation 46.17
|
111.17 "µM/L"
Standard Deviation 96.01
|
|
Serum Total Peroxides
1.5 hours
|
101.64 "µM/L"
Standard Deviation 38.65
|
112.67 "µM/L"
Standard Deviation 88.23
|
|
Serum Total Peroxides
4 hours
|
132.55 "µM/L"
Standard Deviation 43.72
|
137.08 "µM/L"
Standard Deviation 95.05
|
|
Serum Total Peroxides
7 hours
|
122.18 "µM/L"
Standard Deviation 46.42
|
132.75 "µM/L"
Standard Deviation 108.81
|
|
Serum Total Peroxides
6 weeks
|
97.36 "µM/L"
Standard Deviation 39.69
|
99.58 "µM/L"
Standard Deviation 31.84
|
|
Serum Total Peroxides
8 weeks
|
79.27 "µM/L"
Standard Deviation 25.86
|
71.25 "µM/L"
Standard Deviation 25.69
|
|
Serum Total Peroxides
8 weeks - 1.5 hours
|
97.27 "µM/L"
Standard Deviation 22.36
|
86.92 "µM/L"
Standard Deviation 25.04
|
|
Serum Total Peroxides
8 weeks - 4 hours
|
99.91 "µM/L"
Standard Deviation 23.28
|
92.50 "µM/L"
Standard Deviation 24.99
|
|
Serum Total Peroxides
8 weeks - 7 hours
|
89.18 "µM/L"
Standard Deviation 20.04
|
90.17 "µM/L"
Standard Deviation 27.33
|
|
Serum Total Peroxides
14 weeks
|
102.91 "µM/L"
Standard Deviation 23.78
|
115.83 "µM/L"
Standard Deviation 64.46
|
|
Serum Total Peroxides
20 weeks
|
104.91 "µM/L"
Standard Deviation 39.91
|
116.33 "µM/L"
Standard Deviation 105.86
|
SECONDARY outcome
Timeframe: 20 weeksSerum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Total Antioxidant Capacity
Baseline
|
1.15 "mM/L"
Standard Deviation 0.43
|
1.45 "mM/L"
Standard Deviation 0.23
|
|
Serum Total Antioxidant Capacity
1.5 hours
|
1.27 "mM/L"
Standard Deviation 0.31
|
1.24 "mM/L"
Standard Deviation 0.24
|
|
Serum Total Antioxidant Capacity
4 hours
|
1.13 "mM/L"
Standard Deviation 0.33
|
1.23 "mM/L"
Standard Deviation 0.34
|
|
Serum Total Antioxidant Capacity
7 hours
|
1.22 "mM/L"
Standard Deviation 0.44
|
1.39 "mM/L"
Standard Deviation 0.40
|
|
Serum Total Antioxidant Capacity
6 weeks
|
1.45 "mM/L"
Standard Deviation 0.38
|
1.54 "mM/L"
Standard Deviation 0.22
|
|
Serum Total Antioxidant Capacity
8 weeks
|
1.20 "mM/L"
Standard Deviation 0.22
|
1.31 "mM/L"
Standard Deviation 0.29
|
|
Serum Total Antioxidant Capacity
8 weeks - 1.5 hours
|
1.68 "mM/L"
Standard Deviation 0.52
|
1.86 "mM/L"
Standard Deviation 0.30
|
|
Serum Total Antioxidant Capacity
8 weeks - 4 hours
|
1.14 "mM/L"
Standard Deviation 0.38
|
1.30 "mM/L"
Standard Deviation 0.34
|
|
Serum Total Antioxidant Capacity
8 weeks - 7 hours
|
1.38 "mM/L"
Standard Deviation 0.32
|
1.18 "mM/L"
Standard Deviation 0.57
|
|
Serum Total Antioxidant Capacity
14 weeks
|
1.46 "mM/L"
Standard Deviation 0.32
|
1.48 "mM/L"
Standard Deviation 0.33
|
|
Serum Total Antioxidant Capacity
20 weeks
|
1.34 "mM/L"
Standard Deviation 0.28
|
1.47 "mM/L"
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 20 weeksSerum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Endogenous Peroxidase-activity
Baseline
|
3.37 "mU/mL"
Standard Deviation 1.74
|
3.07 "mU/mL"
Standard Deviation 1.09
|
|
Serum Endogenous Peroxidase-activity
1.5 hours
|
3.35 "mU/mL"
Standard Deviation 1.49
|
3.90 "mU/mL"
Standard Deviation 2.03
|
|
Serum Endogenous Peroxidase-activity
4 hours
|
4.37 "mU/mL"
Standard Deviation 1.26
|
4.22 "mU/mL"
Standard Deviation 1.03
|
|
Serum Endogenous Peroxidase-activity
7 hours
|
5.31 "mU/mL"
Standard Deviation 1.13
|
4.84 "mU/mL"
Standard Deviation 0.93
|
|
Serum Endogenous Peroxidase-activity
6 weeks
|
4.36 "mU/mL"
Standard Deviation 0.83
|
4.34 "mU/mL"
Standard Deviation 0.55
|
|
Serum Endogenous Peroxidase-activity
8 weeks
|
6.05 "mU/mL"
Standard Deviation 1.82
|
5.15 "mU/mL"
Standard Deviation 1.24
|
|
Serum Endogenous Peroxidase-activity
8 weeks - 1.5 hours
|
3.97 "mU/mL"
Standard Deviation 1.62
|
3.60 "mU/mL"
Standard Deviation 1.03
|
|
Serum Endogenous Peroxidase-activity
8 weeks - 4 hours
|
3.99 "mU/mL"
Standard Deviation 1.12
|
3.93 "mU/mL"
Standard Deviation 1.41
|
|
Serum Endogenous Peroxidase-activity
8 weeks - 7 hours
|
4.35 "mU/mL"
Standard Deviation 1.30
|
5.48 "mU/mL"
Standard Deviation 1.74
|
|
Serum Endogenous Peroxidase-activity
14 weeks
|
3.89 "mU/mL"
Standard Deviation 1.53
|
4.95 "mU/mL"
Standard Deviation 2.01
|
|
Serum Endogenous Peroxidase-activity
20 weeks
|
3.04 "mU/mL"
Standard Deviation 1.34
|
2.96 "mU/mL"
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 20 weeksSerum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Serum Polyphenols
8 weeks - 4 hours
|
8.25 "mM/L"
Standard Deviation 0.70
|
8.18 "mM/L"
Standard Deviation 0.70
|
|
Serum Polyphenols
8 weeks - 7 hours
|
8.68 "mM/L"
Standard Deviation 0.35
|
8.57 "mM/L"
Standard Deviation 0.40
|
|
Serum Polyphenols
14 weeks
|
8.72 "mM/L"
Standard Deviation 0.52
|
8.82 "mM/L"
Standard Deviation 0.44
|
|
Serum Polyphenols
20 weeks
|
9.67 "mM/L"
Standard Deviation 0.34
|
9.46 "mM/L"
Standard Deviation 0.64
|
|
Serum Polyphenols
Baseline
|
9.88 "mM/L"
Standard Deviation 0.34
|
9.57 "mM/L"
Standard Deviation 0.34
|
|
Serum Polyphenols
1.5 hours
|
9.73 "mM/L"
Standard Deviation 0.45
|
9.77 "mM/L"
Standard Deviation 0.67
|
|
Serum Polyphenols
4 hours
|
9.97 "mM/L"
Standard Deviation 0.38
|
9.81 "mM/L"
Standard Deviation 0.45
|
|
Serum Polyphenols
7 hours
|
9.72 "mM/L"
Standard Deviation 0.31
|
9.54 "mM/L"
Standard Deviation 0.43
|
|
Serum Polyphenols
6 weeks
|
9.49 "mM/L"
Standard Deviation 0.35
|
9.46 "mM/L"
Standard Deviation 0.41
|
|
Serum Polyphenols
8 weeks
|
9.73 "mM/L"
Standard Deviation 0.29
|
9.54 "mM/L"
Standard Deviation 0.53
|
|
Serum Polyphenols
8 weeks - 1.5 hours
|
8.87 "mM/L"
Standard Deviation 0.66
|
8.71 "mM/L"
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 20 weeksTotal Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40
Outcome measures
| Measure |
Panmol-B-Complex
n=14 Participants
Participants first received a natural vitamin B complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
Synthetic Vitamin B-complex
n=15 Participants
Participants first received a synthetic vitamin B complex i.e. B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural vitamin B-complex i.e. Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. The study finished after the second wash-out period for another 6 weeks.
|
|---|---|---|
|
Total Homocysteine
Baseline
|
8.89 "µM"
Standard Deviation 1.99
|
11.49 "µM"
Standard Deviation 7.57
|
|
Total Homocysteine
1.5 hours
|
8.96 "µM"
Standard Deviation 2.32
|
11.89 "µM"
Standard Deviation 8.20
|
|
Total Homocysteine
4 hours
|
8.68 "µM"
Standard Deviation 1.98
|
11.38 "µM"
Standard Deviation 8.01
|
|
Total Homocysteine
7 hours
|
8.91 "µM"
Standard Deviation 2.03
|
11.31 "µM"
Standard Deviation 7.89
|
|
Total Homocysteine
6 weeks
|
7.76 "µM"
Standard Deviation 1.43
|
7.85 "µM"
Standard Deviation 1.89
|
|
Total Homocysteine
8 weeks
|
7.89 "µM"
Standard Deviation 1.58
|
8.16 "µM"
Standard Deviation 1.58
|
|
Total Homocysteine
8 weeks - 1.5 hours
|
7.91 "µM"
Standard Deviation 1.47
|
7.97 "µM"
Standard Deviation 1.45
|
|
Total Homocysteine
8 weeks - 4 hours
|
7.34 "µM"
Standard Deviation 1.45
|
7.39 "µM"
Standard Deviation 1.31
|
|
Total Homocysteine
8 weeks - 7 hours
|
8.00 "µM"
Standard Deviation 1.70
|
8.13 "µM"
Standard Deviation 1.69
|
|
Total Homocysteine
14 weeks
|
7.01 "µM"
Standard Deviation 1.59
|
7.44 "µM"
Standard Deviation 1.55
|
|
Total Homocysteine
20 weeks
|
7.62 "µM"
Standard Deviation 2.03
|
7.95 "µM"
Standard Deviation 1.88
|
Adverse Events
Natural Panmol-B-Complex
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Synthetic Vitamin-B-Complex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Natural Panmol-B-Complex
n=30 participants at risk
Participants received a Natural Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.
|
Synthetic Vitamin-B-Complex
n=30 participants at risk
Participants received a Synthetic Vitamin-B-Complex consisting of - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks (matching the Natural Panmol-B-Complex).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Flush
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/30 • 6 months
|
Additional Information
Dr. Willibald Wonisch
Otto Loewi Research Center, Chair of Physiological Medicine, Medical University of Graz, Austria
Phone: 00436505299540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place