Trial Outcomes & Findings for The Relationship Between Vitamin D and Hepatitis B Virus Replication (NCT NCT03068767)
NCT ID: NCT03068767
Last Updated: 2020-02-12
Results Overview
the serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
baseline, after 2-month vitamin D supplement
Results posted on
2020-02-12
Participant Flow
Chronic HBV patients receiving regular 6-month surveillance in the outpatient clinic of Taipei Tzu Chi Hospital were invited to join the study from August 2017 to September 2018.
All had positive hepatitis B surface antigen (HBsAg) for more than 6 months. Those with positive anti-hepatitis C virus (HCV) antibody, other known causes of chronic hepatitis or receiving antiviral treatment currently were excluded. Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded.
Participant milestones
| Measure |
Vitamin D Group
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D
|
Control Group
Patients without receiving vitamin D supplement
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
COMPLETED
|
65
|
71
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Vitamin D Group
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D
|
Control Group
Patients without receiving vitamin D supplement
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Protocol Violation
|
3
|
0
|
Baseline Characteristics
Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
Baseline characteristics by cohort
| Measure |
Total
n=149 Participants
Total of all reporting groups
|
Vitamin D Group
n=75 Participants
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D
|
Control Group
n=74 Participants
Patients without receiving vitamin D supplement
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=149 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
133 Participants
n=149 Participants
|
65 Participants
n=75 Participants
|
68 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=149 Participants
|
10 Participants
n=75 Participants
|
6 Participants
n=74 Participants
|
|
Age, Continuous
|
51.61 years
STANDARD_DEVIATION 9.86 • n=149 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
51.85 years
STANDARD_DEVIATION 10.88 • n=75 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
51.28 years
STANDARD_DEVIATION 8.86 • n=74 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
|
Sex: Female, Male
Female
|
83 Participants
n=149 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
43 Participants
n=75 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
40 Participants
n=74 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
|
Sex: Female, Male
Male
|
66 Participants
n=149 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
32 Participants
n=75 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
34 Participants
n=74 Participants • Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
|
|
Race and Ethnicity Not Collected
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline, after 2-month vitamin D supplementthe serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement
Outcome measures
| Measure |
Vitamin D Group
n=75 Participants
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D
|
Control Group
n=74 Participants
Patients without receiving vitamin D supplement
|
|---|---|---|
|
The Dynamic Change of HBV DNA
|
3.15 IU/mL
Standard Deviation 1.14
|
3.14 IU/mL
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: baseline, after 2-month vitamin D supplementPopulation: Levels of qHBsAg before and after 2 months of vitamin D treatment or follow-up were compared between these two groups.
The serum qHBsAg levels were measured before and after 2-month vitamin D supplement
Outcome measures
| Measure |
Vitamin D Group
n=75 Participants
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D
|
Control Group
n=74 Participants
Patients without receiving vitamin D supplement
|
|---|---|---|
|
The Change of Serum qHBsAg (IU/mL)
|
2.19 IU/mL
Standard Deviation 1.03
|
2.4 IU/mL
Standard Deviation 1.11
|
Adverse Events
Vitamin D Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D Group
n=75 participants at risk
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D
No serious adverse events noted.
|
Control Group
n=74 participants at risk
Patients without receiving vitamin D supplement
No serious adverse events noted.
|
|---|---|---|
|
Eye disorders
tearing
|
0.00%
0/75 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
1.4%
1/74 • Number of events 1 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
|
Renal and urinary disorders
urine occult blood positive
|
1.3%
1/75 • Number of events 1 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
0.00%
0/74 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.7%
2/75 • Number of events 2 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
0.00%
0/74 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/75 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
1.4%
1/74 • Number of events 1 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
|
Ear and labyrinth disorders
sneezing
|
0.00%
0/75 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
2.7%
2/74 • Number of events 2 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
|
Gastrointestinal disorders
acid reflux
|
0.00%
0/75 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
1.4%
1/74 • Number of events 1 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
|
Musculoskeletal and connective tissue disorders
leg soreness
|
0.00%
0/75 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
1.4%
1/74 • Number of events 1 • 2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
|
Additional Information
Chief of internal medicine department
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Phone: +886-2-6628-9779
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place