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. 2015 Oct 27;2015(10):CD008666. doi: 10.1002/14651858.CD008666.pub3

Radhika 2003.

Methods "double‐blinded, randomized, controlled study."
Participants Inclusion criteria:
  • 16 and 24 weeks' gestation;

  • willing to have a follow‐up every 2 weeks and who resided in the city area were chosen for the study.


Exclusion criteria: women with recurrent pregnancy loss or earlier preterm delivery and those with diabetes, hypertension, or any other metabolic disorder.
Interventions Intervention group: 85 women received red palm oil providing 2173 to 2307 µg of β‐carotene per day with a dosage schedule of 1 sachet per day (8 mL), which provided 91% to 96% of the daily requirement of vitamin A in pregnancy, (i.e. 2400 µg of β‐carotene which is equivalent to 3000 IU of vitamin A) daily for a period of 8 weeks.
Control group: 85 women received 1 sachet of groundnut oil (8 mL) for a period of 8 weeks.
Outcomes Primary outcome: maternal and neonatal vitamin A status.
Other outcomes: Hb levels in mother and baby, preterm birth (delivery less than 37 completed weeks as confirmed by ultrasound examination), birthweight and gestational age.
Notes Vitamin A levels were measured before starting supplementation.
Country: India.
Study setting: the outpatient department of Niloufer Hospital,  Hyderabad, India.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and personnel "Double blind".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information given.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 41 (24.1%) women were excluded from the analysis: 23 were not available for supplementation, while 18 dropped out after initiating supplementation.
Overall, the loss to follow‐up of the intervention group was 9.5 % and the control group was 15.1%.
Selective reporting (reporting bias) Unclear risk The protocol of the study is not available at the moment.
Other bias Low risk No other bias awarded.