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. 2017 Mar 10;2017(3):CD008524. doi: 10.1002/14651858.CD008524.pub3

Venkatarao 1996.

Methods Individually randomised trial conducted in India
Participants Eligibility: infants aged 6 months were included
Sample: 909 infants were randomised to 3 intervention groups. Proportion of boys in the study was 50%
Interventions The 3 intervention groups were as follows:
  1. Group AA: mother received and infants both received vitamin A

  2. Group AP: mother received vitamin A while infant received placebo

  3. Group PP: both mother and infant received placebo


Dose of vitamin A for infant was 200,000 IU
Outcomes All‐cause mortality and cause‐specific mortality due to diarrhoea and respiratory disease. Incidence of diarrhoea and respiratory disease morbidity
Notes We have included the data for groups AA vs AP
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Each pair of subjects enrolled for the study was randomly allocated to one of the following three groups: (i) AA‐Both mother and infant received Vitamin A, the former soon after delivery and the latter at 6 months; (ii) AP: mother received Vitamin A but her infant received a placebo (Sesame oil); and (iii) PP: both mother and infant received placebo, the former Vitamin E and the latter Sesame oil."
Comment: insufficient detail to form judgment
Allocation concealment (selection bias) Unclear risk Comment: insufficient detail to form judgment
Blinding (performance bias and detection bias) 
 Blinding of Participants Low risk Quote: "At the age of 6 to 6Vi months, the infant was weighed again and given the appropriate syrup by the Medical Officer from coded bottles, supplied again by the Statistical Section at the Camp Office."
Comment: probably done
Blinding (performance bias and detection bias) 
 Blinding of provider Low risk Comment: as above; probably done
Blinding (performance bias and detection bias) 
 Blinding of outcome assessor Low risk Comment: as above; probably done
Incomplete outcome data (attrition bias) Unclear risk Quote: "4 each in the AA and AP groups and 5 in the PP group were withdrawn from the trial on medical grounds such as congenital abnormalities, epileptic fits or jaundice. Migration accounted for the loss of 34 infants in the AA group, 25 in the AP group and 20 in the PP group while 7, 9 and 7 were excluded due to other miscellaneous reasons. Of the remaining 263, 255 and 256 infants in the three group, 233 in the AA and 228 each in the AP and PP groups were followed‐up very regularly and form the basis for analyses in this report."
Comment: they provided specific information about losses by group. However, it is unclear why 263, 255 and 256 infants that remain in the 3 groups after attrition is described in the Results as only 233 in the AA and 228 each in the AP and PP groups being used as the basis for analysis.
Selective reporting (reporting bias) Unclear risk Comment: does not reference a protocol or trial registration number and does not state that all measured outcomes are reported
Other bias Low risk Quote: "Quality control of the morbidity data collected by the field investigators was undertaken throughout. As long recall periods pose problems, the collection of morbidity data was intensified from once a fortnight to once a week when the study had been in progress for 9 months."
Comment: authors attempted to minimise other biases such as recall bias, though specific details of "quality control" are not provided.