The pharmacogenetics of vitamin D response in tuberculosis - The pharmacogenetics of vitamin D response in tuberculosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023189-27-GB

Enrollment

160

Registered

2010-11-23

Start date

2011-01-20

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Trade Name: Cholecalciferol (Dekristol capsules) Product Name: Dekristol® 20,000IU Pharmaceutical Form: Capsule* INN or Proposed INN: cholecalciferol CAS Number: 67970 Concentration unit: IU internati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients will be eligible for inclusion if they have a microbiologically confirmed diagnosis of tuberculosis, are aged over 16 years and able to consent to research. A positive microbiological diagnosis will be defined by positive MTb culture or positive ZN stain in the setting of clinical suspicion of MTb infection. Patients will be enrolled at the start of their anti-TB treatment only. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients being managed with regimes outside of the standard NICE guidance, or with drug resistant MTb, will be excluded. Other exclusion criteria are listed in the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome will be the interaction between vitamin D binding protein genotype (GC genotype) and pre-supplementation vitamin D level in determining post-supplementation vitamin D level ;Secondary Objective: Secondary outcomes will include 1. The relationship of TB outcomes to vitamin D level and the interaction above. Clinical improvement will be defined by change in TB score, sputum bacteriology and radiology 2. The relationship of vitamin D binding protein (DBP) concentration to TB severity 3. The inter-relationship of vitamin D, DBP and other inflammatory markers with each other ;Primary end point(s): The primary outcomes will be the interaction between vitamin D binding protein genotype (GC genotype) and pre-supplementation vitamin D level in determining post-supplementation vitamin D level.	—

Measure

Time frame

Main Objective: The primary outcome will be the interaction between vitamin D binding protein genotype (GC genotype) and pre-supplementation vitamin D level in determining post-supplementation vitamin D level ;Secondary Objective: Secondary outcomes will include 1. The relationship of TB outcomes to vitamin D level and the interaction above. Clinical improvement will be defined by change in TB score, sputum bacteriology and radiology 2. The relationship of vitamin D binding protein (DBP) concentration to TB severity 3. The inter-relationship of vitamin D, DBP and other inflammatory markers with each other ;Primary end point(s): The primary outcomes will be the interaction between vitamin D binding protein genotype (GC genotype) and pre-supplementation vitamin D level in determining post-supplementation vitamin D level.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026