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Abstract: TH-PO244

Once Daily versus Twice Daily Oral Iron for Iron Repletion in CKD: A Randomized, Controlled, Open Label Trial

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical

Authors

  • Kumar, Vivek, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Sood, Vivek Dr, PGIMER, New Delhi, India
  • Malhotra, Samir, PGIMER, New Delhi, India
  • Gupta, Krishan Lal L., Postgraduate Institute of Medical Education & Research, Chandigarh, India
  • Kamboj, Kajal, PGIMER Chandigarh, Chandigarh, India
Background

In healthy individuals, the amount of iron absorbed with once daily (OD) dosing has been shown to be as good as with twice daily (BD) dosing despite double cumulative dose with BD dosing. Increase in serum hepcidin impairs absorption from subsequent dose when multiple doses are given. Oral iron supplementation, given as divided daily doses, is commonly prescribed in pre-dialysis CKD as iron deficiency and anemia are common. Therefore, in view of recent findings of impaired iron absorption with multiple daily dosing in normal individuals, we decided to compare iron repletion by OD versus BD oral iron dosing in subjects with stage G3-4 CKD and iron deficiency. The primary objective was difference in change in % transferrin saturation (%TS) between groups over 12 weeks. The main secondary objectives were differences in change in serum ferritin and blood hemoglobin over 12 weeks.

Methods

In this open label, randomized, controlled trial (CTRI/2017/02/007799 at ctri.nic.in), stable adult subjects with CKD stage G3-4 and iron deficiency (%TS <30 % and serum ferritin <500 ng/ml) were randomized (1:1) to receive tablets of ferrous ascorbate (equivalent to 100 mg elemental iron) in either OD (one tablet daily, total 100 mg) or BD (one tablet twice daily, total 200 mg) dosage. Hemoglobin <9 g/dL, iron use in last 3 months, previous gastrointestinal disease, bleeding or use of anti-acid drugs were exclusion criteria. Repeated measure ANOVA was used to assess change in % TSAT and serum ferritin over 2, 6 and 12 weeks in either dosage group and test the interaction of dosage form with change in % TSAT and serum ferritin in study population.

Results

Out of 328 screened subjects, 80 were enrolled. At baseline, the groups were similar except for higher hemoglobin and eGFR in the OD group. In both groups, there were significant effects (increase) of the dosage group on % TS and serum ferritin. However, there were no interaction between the dosage group and change in %TS [Wilks’ Lambda=0.951, F (3, 222) = 1.359, p=0.258] or change in serum ferritin [Wilks’ Lambda=0.916, F (2.533, 187.450) = 2.666, p=0.059] or change in hemoglobin. Interestingly, there was significant interaction of dosage group with change in MCHC with significant rise in OD group (p < 0.001).

Conclusion

Iron incorporation in hemoglobin might be better with OD dosing.

Funding

  • Government Support - Non-U.S.