Data collection, management and statistical analysis
PTB, Tuberculosis
EVENT, TUBERCULOSIS, REGRESSION, BLOOD, RELAPSE
Random Allocation Sequence was generated by a Senior Research Fellow, who also kept secure the codes of the intervention and was not involved in the distribution of the packets and none of the participants, care providers, clinical and laboratory investigators (except for the Senior Research Fellow) were informed of the treatment assignment. Packets containing the two interventions were prepared in advance according to the randomization numbers, arranged in serial order and distributed consecutively to the patients according to their entry into the trial.As per Revised National Tuberculosis Control Program annual report (2013), 12% of PTB patients receiving category-I ATT had relapse. Assuming that vitamin D supplementation for 24 months (6 months with ATT and 18 months post ATT), would reduce the relapse by 6% by the end of two years from diagnosis. To detect a 6% reduction (12% vs 6%) in the relapse between the two arms in a two-sided test with 5% alpha error and 80% power, 356 participants were required in each group (as per the nQuery Advisor Version 2.0). Giving an allowance of 5% each for losses in follow-up and MDR detection after randomization, 396 participants would be required per group. Therefore, we need to randomize about 800 participants.The data was analyzed using STATA version 16.0.0. Blood, urine and radiological parameters were analyzed using parametric and non-parametric analysis. Parametric data was analyzed using Student’s t-test, while non-parametric data was analyzed using Wilcoxon rank sum test. Sputum smear and culture data was analyzed using Log rank test as all covariates were balanced in the two groups at baseline. for equality of survivor functions. Relapse data was analyzed using Log-rank test for equality of survivor functions in STATA. Cox regression was used to calculate the hazard ratio and 95% confidence interval for the time to event data.The protocol was followed as per the Good Clinical Practice standards and Institutional Ethical Guidelines. The protocol was approved by Institutional ethics committee of all three centers (Reference number: AIIMS IEC-256/06.05.2016, RP-1/2016). Written informed consent was taken from all the participants. For participants below the age of 18, written informed consent was provided by their legal guardians. The trial protocol was registered with the Clinical Trial Registry–India. Participants were screened and recruited from February 1, 2017 and followed up till February 27, 2021.