Villar 1987.
Methods | Double‐blind, RCT | |
Participants | Recruitment 1983‐1985. 34 black women from Johns Hopkins Hospital, Baltimore, USA, 18 white women from Rosario, Argentina Inclusion criteria: nulliparous or primiparous; known menstrual dates; age 18‐30 years; singleton pregnancy; negative roll‐over test. Exclusion criteria: underlying medical disorders. Mean calcium intake at 26 weeks was: calcium group: 1129 (SD 736) and placebo group 914 (478). |
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Interventions | Calcium carbonate 1.5 g (500 mg tablets) from 26 weeks' gestation vs placebo tablets. Women at Johns Hopkins Hospital also received vitamin preparations containing 200 mg calcium and 100 mg magnesium per day. | |
Outcomes | Weight gain in last trimester of pregnancy; BP increase; gestational hypertension | |
Notes | Source of funding: grants from the National Dairy Board and the National Dairy Council. CoI: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 'Randomly assigned' ‐ no other details |
Allocation concealment (selection bias) | Low risk | Random numbers in closed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Tablets were the same weight, size and colour, prepared by The Johns Hopkins pharmacy and distributed to the 2 hospitals. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Tablets were the same weight, size and colour, prepared by The Johns Hopkins pharmacy and distributed to the 2 hospitals. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | < 10% attrition |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported |
Other bias | Unclear risk | Women at Johns Hopkins Hospital only also received vitamin preparations containing 200 mg calcium/day. |