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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 47
Population
47 newly diagnosed EPTB patients
Methods
Randomized assignment to vitamin D3 supplementation (50,000 IU weekly for 6 weeks then 1000 IU daily) plus anti-TB drugs vs anti-TB drugs alone; follow-up at 3 months for serum 25(OH)D3 and clinical outcomes.
Duration
6 months
Funding
Unclear

Background

We aimed to assess serum 25-hydroxyvitamin D3 (25(OH)D3) concentrations in extrapulmonary tuberculosis (EPTB) patients and to evaluate the effect of vitamin D3 supplementation on their treatment course.

Methods

Serum 25(OH)D3concentrations were measured in 47 newly diagnosed EPTB patients and 42 controls. Vitamin D-deficient EPTB patients were randomly assigned to receive 50,000 IU of vitamin D3 (cholecalciferol) orally once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1000 IU a day besides anti-TB drugs or the first line anti-TB treatment only. Follow up serum 25(OH)D3 concentrations were measured after 3 months of starting vitamin D3 supplementation. Both groups were evaluated for clinical, laboratory, and radiological outcomes after treatment.

Results

Serum 25(OH)D3 concentrations were significantly lower among TB cases (17.1 ± 5.5 nmol/L) compared to healthy controls (51.8 ± 27.3 nmol/L), and vitamin D deficiency was observed in all EPTB patients (n = 47). Patients in VD3 supplementation group had significantly higher weight gain and serum albumin level at 2 months and end of treatment, higher hemoglobin concentration at the end of treatment, significantly lower CRP and ESR at 2 months and at the end of treatment. In cases with TB pleurisy, a significant higher rate of full resolution of pleural fluid after 6 months of anti-TB treatment and shorter treatment duration were noted compared to the other group.

Conclusions

Vitamin D deficiency is prevalent in EPTB patients, in whom, vitamin D supplementation is a useful adjunctive therapy to anti-TB drugs and improves treatment course.

Research Insights

  • Patients in VD3 supplementation group had significantly higher weight gain and serum albumin level at 2 months and end of treatment

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
  • higher hemoglobin concentration at the end of treatment

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
  • Patients in VD3 supplementation group had significantly higher weight gain and serum albumin level at 2 months and end of treatment

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
  • significantly lower CRP and ESR at 2 months and at the end of treatment

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
  • significantly lower CRP and ESR at 2 months and at the end of treatment

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
  • a significant higher rate of full resolution of pleural fluid after 6 months of anti-TB treatment and shorter treatment duration were noted compared to the other group

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
  • a significant higher rate of full resolution of pleural fluid after 6 months of anti-TB treatment and shorter treatment duration were noted compared to the other group

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    50,000 IU once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1,000 IU/day
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