Ajans 1965.
Methods | RCT. | |
Participants | Inclusion criteria: 44 parturient women in good health from the lower and middle socioeconomic groups (in a population in which vitamin A deficiency occurs). | |
Interventions | Intervention group 1: 15 women. Single intramuscular injection of 600,000 lU of vitamin A palmitate in oil at parturition. 4 samples of 2 to 3 mL of colostrum were collected. 1 antepartum sample and 3 postpartum samples, 1 on each consecutive day of hospitalisation. Intervention group 2: 11 women. Given 600,000 lU of water‐dispersible vitamin A palmitate orally shortly before delivery. 4 samples of 2 to 3 mL of colostrum were collected. 1 antepartum sample and 3 postpartum samples, 1 on each consecutive day of hospitalisation. Followed by public health nurses at their homes where bi‐weekly samples of milk were collected during the first week after discharge and then weekly samples for a total period ranging between 38 and 59 days postpartum. Control group: 18 women not given any form of vitamin A therapy prepartum. 4 samples of 2 to 3 mL of colostrum were collected. 1 antepartum sample and 3 postpartum samples, 1 on each consecutive day of hospitalisation. |
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Outcomes | Primary outcome: levels of vitamin A and carotenoids in the maternal blood. Other outcomes: levels of vitamin A and carotenoids in the colostrum prenatal and postnatal. | |
Notes | Vitamin A levels measured before starting supplementation in group 1 and 2. Study was done in a population in which vitamin A deficiency occurs. Study setting: American university hospital. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description except allotted at random. |
Allocation concealment (selection bias) | Unclear risk | No description except allotted at random. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding methods were reported. The routes of medication administration methods varied across groups. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No exclusion or loss of follow‐up reported. |
Selective reporting (reporting bias) | Unclear risk | The protocol of the study is not available at the moment. |
Other bias | High risk | The 3 groups were not studied during the same period. The authors reported "subjects in groups 1 and 2 were studied in the summer and those of group 3 in the following winter". |