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OpenTrials
Completed

NCT Number: NCT03068767

The Relationship Between Vitamin D and Hepatitis B Virus Replication

149 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is supplied with vitamin D and another without as controls. The markers of HBV replication were compared before and after treatment.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, 23142, Taiwan

About this study

This is a randomized case-control trial. A total of 149 HBV carriers with inadequate vitamin D (< 30 ng/mL) level were enrolled. They were randomly divided to two groups: one group receiving vitamin D supplement (1600 IU/day) for 2 months and another group as controls. The serum vitamin D, HBV DNA and qHBsAg levels were measured at baseline and after vitamin D supplement. Whether HBV DNA and qHBsAg have significant change after vitamin D supplement can be determined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >20 y/o, HBV carrier
  • serum vitamin D < 30ng/ml

Exclusion criteria

  • Other known causes of hepatitis

Treatment and study plan

Vitamin D

Dietary Supplement

Primary outcomes

  1. The Dynamic Change of HBV DNA

    Time frame: baseline, after 2-month vitamin D supplement

    the serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement

  2. The Change of Serum qHBsAg (IU/mL)

    Time frame: baseline, after 2-month vitamin D supplement

    The serum qHBsAg levels were measured before and after 2-month vitamin D supplement

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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