Marya 1988.
Methods | Randomised clinical trial; 2‐arm design with individual randomisation. | |
Participants | 200 pregnant women, aged 22 to 35 years old, attending the antenatal clinic of the Medical College Hospital, Rohtak, India (latitude: 76° 34' 0' north of Tropic of Cancer). Inclusion criterion: uncomplicated single pregnancy. Exclusion criteria: pre‐eclampsia, antepartum haemorrhage, premature delivery. Pre‐gestational BMI and skin pigmentation not reported. | |
Interventions | Participants were allocated to 1 of the following groups: group 1 (n = 100) women received 2 doses of 600,000 IU (each dose at 7th and 8th month of pregnancy (estimated total dose: 1,200,000 IU); group 2 (n = 100) women received no intervention and served as controls. Length of the intervention/follow‐up: 12 weeks from start of supplementation to term. Health worker cadre: not specified. |
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Outcomes | Maternal: venous and cord serum calcium, serum proteins, inorganic phosphate, alkaline phosphatase, weight. Radiological examination on women with abnormal biochemistry or osteomalacia symptomatology. Side effects: back age, leg‐pains, general weakness, cramps. Infant: birthweight, LBW, crown‐heel length, head circumference, mid‐arm circumference within 24 hours after birth. Skinfold thickness (triceps and infrascapular). Laboratory method used for assessment of vitamin D concentrations: not applicable. |
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Notes |
Source of funding: unknown/unreported. Dates of the study and location: not reported dates, India. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): none declared. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial reported that participants were randomly allocated to the intervention groups but they did not report the method of sequence generation. |
Allocation concealment (selection bias) | Unclear risk | The trial did not report the method of concealment. It is assumed that they did not conceal the allocation as one of the groups did not receive any supplementation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial did not report if the study was blinded. It is assumed that it was not blinded to participants as one of the groups did not receive any supplementation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial did not report if the research staff was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses to follow‐up are not documented although exclusions included pregnancy complications. Results tables mention that each arm was comprised of 100 women, a number that corresponds to that described for the treatment allocation. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Low risk | The study appears to be free of other sources of bias. |