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. 2018 Jul 19;2018(7):CD011597. doi: 10.1002/14651858.CD011597.pub2

Choudhary 2012.

Methods Study design: randomised, double‐blind, placebo‐controlled trial
Study duration: not reported
Participants Inclusion criteria
  • Setting: hospital inpatients department

  • Country: India

  • Health condition: children aged 2 months to 5 years hospitalised with severe pneumonia

  • Number: N = 200; treatment (100); control (100)

  • Age (mean, SD/median, range)

    • Treatment: 14.1 ± 12.2 months

    • Control: 13.8 ± 11.4 months

  • Sex (m/f): not reported

  • Other information: history of recurrent pneumonia was present in 30% of intervention group and 33% of control group. 5 children had clinical evidence of rickets. One‐third of children had wheezing at enrolment.


Exclusion criteria
  • Children with severe wasting (weight for height < 3 SD), chronic illnesses, previous history of vitamin D intake over last 4 weeks, and known asthmatics were excluded.

Interventions Treatment group
  • Intervention: vitamin D₃

  • Dose, duration, frequency: oral vitamin D₃ was given for 5 days at doses of 1000 IU for children aged up to 1 year and 2000 IU for children aged over 1 year


Control group
  • Intervention: lactose

  • Dose, duration, frequency: 200 mg once daily for 5 days


Co‐interventions
  • Antibiotics were administered as per the IAP 2006 guidelines (< 3 months: cefotaxime/ceftriaxone ± gentamicin/amikacin as first line, and co‐amoxyclav + gentamicin/amikacin as second line; 3 months to 5 years: ampicillin/chloramphenicol or ampicillin + chloramphenicol or co‐amoxyclav as first line, and co‐amoxyclav or cefotaxime/ceftriaxone as second line. In staphylococcal infection, cloxacillin as first line and vancomycin/teicoplanin as second line was added to any of the above combinations in the respective age groups).

Outcomes Primary
  • Time to resolution of severe pneumonia (absence of lower chest indrawing, hypoxia, cyanosis, lethargy, and inability to feed)


Secondary
  • Duration of hospitalisation, time to resolution of tachypnoea, fever, hypoxia, chest retraction, and inability to feed/lethargy

Notes Funding source: not funded by any funding agency
Other: microbiological and radiological diagnosis of pneumonia was not done. Serum vitamin D₃ level was not measured.
Contact with study authors: email: 24 April 2016. Data were reported in median and IQR; we requested data in mean and SD, but this information was unavailable.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer randomisation
Allocation concealment (selection bias) Low risk Sealed envelopes were used.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of participants and caretaker was ensured and unlikely that the blinding could have been broken, as both the intervention and placebo looked alike in terms of appearance, taste, and colour.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The code key was opened only after the intervention, data collection, follow‐up, and tabulation were completed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 4.5% (9/200) children lost to follow‐up or died
Selective reporting (reporting bias) Unclear risk The trial was not registered, so this was unclear, but all outcomes proposed in the methods section were reported.
Other bias Low risk No other known risks of bias