Radhika 2003.
Methods | "double‐blinded, randomized, controlled study." | |
Participants | Inclusion criteria:
Exclusion criteria: women with recurrent pregnancy loss or earlier preterm delivery and those with diabetes, hypertension, or any other metabolic disorder. |
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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. |
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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. |
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Notes | Vitamin A levels were measured before starting supplementation. Country: India. Study setting: the outpatient department of Niloufer Hospital, Hyderabad, India. |
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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. |