The impact of different doses of oral iron supplementation during pregnancy: a pilot randomized trial.

The burden of iron-deficiency anemia remains significant during pregnancy. Oral iron is first-line medication, but there is uncertainty about a range of factors including adherence and side-effects of different doses. We conducted a pilot randomized trial to investigate the impact of different doses of oral iron supplementation started early in pregnancy, in non-anemic women, for four main outcomes; recruitment and protocol compliance, adherence, maintenance of maternal hemoglobin and side-effects. Participants at antenatal clinic visits were allocated to one of three trial arms, in a 1:1:1 ratio, as 200mg ferrous sulphate daily, alternate days or three-times per week, with follow-up to delivery. Baseline characteristics of 300 recruited participants were well matched between trial arms. The mean proportion of tablets taken as expected per participant was 82.5% overall (72.3%, 89.6% and 84.5% for the daily, alternate days and three-times a week arm, respectively). There was a lower overall adherence rate in the daily arm (47%) compared with alternate days (62%) and three times per week (61%). Reduction in hemoglobin between randomization and 28 weeks appeared smaller for the daily arm. A range of side-effects were commonly reported at baseline before starting interventions, and by later antenatal visits. Many side effects of iron overlapped with normal pregnancy symptoms. A daily iron dosing schedule might give the best opportunity for delivering an adequate iron load during pregnancy in non-anemic women. Further randomized trials powered on clinical outcomes are needed to establish the clinical effectiveness of oral iron supplementation to prevent iron deficiency anemia. (ISRCTN12911644).

Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial.

Kidney transplantation is the optimal treatment for end-stage renal disease, but it is still severely limited by a lack of suitable organ donors. Kidneys from donation after circulatory death (DCD) donors have been used to increase transplant rates, but these organs are susceptible to cold ischemic injury in the storage period before transplantation, the clinical consequence of which is high rates of delayed graft function (DGF). Normothermic machine perfusion (NMP) is an emerging technique that circulates a warmed, oxygenated red-cell-based perfusate through the kidney to maintain near-physiological conditions. We conducted a randomized controlled trial to compare the outcome of DCD kidney transplants after conventional static cold storage (SCS) alone or SCS plus 1-h NMP. A total of 338 kidneys were randomly allocated to SCS (n = 168) or NMP (n = 170), and 277 kidneys were included in the final intention-to-treat analysis. The primary endpoint was DGF, defined as the requirement for dialysis in the first 7 d after transplant. The rate of DGF was 82 of 135 (60.7%) in NMP kidneys versus 83 of 142 (58.5%) in SCS kidneys (adjusted odds ratio (95% confidence interval) 1.13 (0.69-1.84); P = 0.624). NMP was not associated with any increase in transplant thrombosis, infectious complications or any other adverse events. A 1-h period of NMP at the end of SCS did not reduce the rate of DGF in DCD kidneys. NMP was demonstrated to be feasible, safe and suitable for clinical application. Trial registration number: ISRCTN15821205 .