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A study to determine the effect of adjunct Vitamin D treatment in pulmonary tuberculosis patients with Vitamin D deficient.

A prospective interventional randomized parallel group active controlled double blind clinical trial to determine the effect of adjunct Vitamin D treatment on DLC, ESR, serum ADA, serum CRP, Oxygen Saturation, and Body Weight in Vitamin D deficient pulmonary tuberculosis patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037914
Enrollment
130
Registered
2021-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Adjunct Vitamin D3 supplementation and standard ATT (anti-tubercular treatment).: Each individual of intervention group will receive standard ATT and 4 doses of 2.5 mg (100000 IU) of Vi

Sponsors

Dr Harish Chandra
Lead Sponsor
Indian Council of Medical Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed stable Pulmonary Tuberculosis patients with Vitamin D deficiency.

Exclusion criteria

Exclusion criteria: With history and biochemical evidence :- 1. Patient with extra pulmonary tuberculosis and drug resistant tuberculosis like MDR-TB, XDR-TB etc. 2. Chronic pulmonary disease like COPD, bronchial asthma, bronchiectasis, pulmonary fibrosis, pulmonary silicosis, sarcoidosis and pulmonary lobectomy. 3. Chronic Liver disease, Aspartate transaminase or Alanine transaminase more than 120 IU per Litre or total serum bilirubin more than 40 micromol per Litre. 4. Chronic Kidney disease, Nephrolithiasis, serum creatinine more than 250 micromol per Litre. 5. Malignancy 6. HIV infection 7. Hyperparathyroidism 8. Thyrotoxicosis 9. Chronic cardiac disease like angina, congestive heart failure, myocardial infarction, arrhythmia etc. 10. Cytotoxic drugs or other immunosuppressant treatment in the month preceding enrollment. 11. Serum corrected calcium more than 2.65 mmol per Litre. 12. Pregnant or breastfeeding. 13. Diabetes Mellitus. 14. Use of drugs affecting Vitamin D metabolism - Anticonvulsants, Glucocorticoids, Calcium and Theophylline.

Design outcomes

Primary

MeasureTime frame
Effect of adjunct Vitamin D treatment on the DLC, ESR, serum ADA, and serum CRP.Timepoint: AT 2 week, 4 week, 6 week and 8 week of treatment period.—

Secondary

MeasureTime frame
Effect of adjunct Vitamin D treatment on Oxygen saturation (SpO2) and Body weight.Timepoint: At 2 week, 4 week, 6 week, 8 week and 12 week of treatment period.—

Countries

India

Contacts

Public ContactDr Harish Chandra

Uttar Pradesh University of Medical Sciences

dradilrahman@yahoo.co.in9410641429

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026