Summary of findings 2. Vitamin D plus calcium versus vitamin D for the treatment of nutritional rickets in children.
Vitamin D plus calcium versus vitamin D for the treatment of nutritional rickets in children | ||||||
Patients: children with nutritional rickets Settings: outpatients Intervention: vitamin D + calcium Comparison: vitamin D | ||||||
Outcomes | Vitamin D | Vitamin D + calcium | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments |
Healing of rickets (number) Definition: normal alkaline phosphatase and bone radiograph Follow‐up: 24 weeks |
189 per 1000 | 579 per 1000 (282 to 1190) | RR 3.06 (1.49 to 6.29) | 75 (1) | ⊕⊕⊝⊝ Lowa | — |
Morbidity (number) Definition: fractures Follow‐up: 24 weeks |
108 per 1000 | 26 per 1000 (3 to 225) | RR 0.24 (0.03 to 2.08) | 75 (1) | ⊕⊝⊝⊝ Very lowb | — |
Adverse events (number) Definition: asymptomatic hypercalcaemia and hypercalciuria Follow‐up: 12 weeks |
See comment | RR 4.76 (0.24 to 93.19) | 39 (1) | ⊕⊝⊝⊝ Very lowc | 2/20 children in the vitamin D + calcium group vs 0/19 children in the vitamin D alone group had an adverse event. | |
All‐cause mortality | Not reported | — | ||||
Health‐related quality of life | Not reported | — | ||||
Growth pattern | Not reported at time point stipulated in protocol (≥ 1 years after commencement of therapy) | — | ||||
Socioeconomic effects | Not reported | — | ||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio. | ||||||
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. |
*Assumed risk was derived from the event rates in the comparator groups. aDowngraded two levels because of serious imprecision (small number of participants, one study only), see Appendix 15. bDowngraded three levels because of very serious imprecision (small number of participants, one study only, and CI consistent with benefit and harm), see Appendix 15. cDowngraded three levels because of risk of bias (performance bias and attrition bias) and very serious imprecision (small number of participants, one study only, and CI consistent with benefit and harm), see Appendix 15.