Once daily versus twice daily oral iron supplementation for iron deficiency in chronic kidney disease

Not Applicable

Completed

• Conditions: Health Condition 1: null- Iron deficient subjects with stage G3-4 chronic kidney disease

• Registration Number: CTRI/2017/02/007799
• Lead Sponsor: Dr Vivek Kumar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-24
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Iron deficiency defined as TSAT <30 % and serum ferritin <500 mg/L.

2.Clinically stable course for last 3 months

Exclusion Criteria

1.Blood haemoglobin <10 g/dl

2.Current use or use within last 3 months of oral or intravenous iron preparations

3.Known/ suspected diagnosis of autoimmune disease

4.Past or present diagnosis of malignancy

5.Known diagnosis of chronic liver disease

6.History of any bleeding diathesis

7.History of gastro-intestinal surgery

8.Present or past diagnosis of peptic ulcer disease, gastro-intestinal bleeding or any form of gastro-intestinal disease predisposing to malabsorption

9.Currently taking gastric acid inhibitors (H2 receptor blockers, proton pump inhibitors)

10.History of allergic reactions to any form of oral or intravenous iron preparations

11.History of prior non-compliance with oral iron therapy on account of gastro-intestinal side effects

12.Current use or use within last 6 months of immunosuppressive drug therapy

13.Pregnancy or lactation, in case of females

14.Life expectancy <1 year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in % transferrin saturation with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. <br/ ><br> <br/ ><br>Timepoint: 12 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
-Change in serum ferritin at 12 weeks with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. <br/ ><br>-Change in blood haemoglobin levels at 12 weeks with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. <br/ ><br>-Change in serum hepcidin levels at 12 weeks with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. <br/ ><br>Timepoint: 12 weeks