Different Oral Iron Dosing Regimens in Treatment of Iron Deficency Anemia in Patients With Chronic Kidney Disease

NCT06521216 | Not Yet Recruiting

• 1 other identifier: Oral iron in CKD patients
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients

Conditions

CKD

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin level by gm/dl

  Follow up Hemoglobin level in 3 groups

  6 months

Study Arms (3)

patients will receive oral iron in alternate day regimen

50 patients will receive oral ferrous sulphate in alternate day regimen

Drug: Ferrous sulfate

patients will receive oral iron in single daily dose regimen

50 patients will receive oral ferrous sulphate in single daily dose regimen

Drug: Ferrous sulfate

patients will receive oral iron in thrice daily dose regimen

50 patients will receive oral ferrous sulphate in thrice daily dose regimen

Drug: Ferrous sulfate

Interventions

Ferrous sulfate DRUG

all patients will receive 200 mg elemental iron (ferrous sulphate)

patients will receive oral iron in alternate day regimen; patients will receive oral iron in single daily dose regimen; patients will receive oral iron in thrice daily dose regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients above 18 years old with CKD stages 2,3 and 4

You may qualify if:

• All adult patients above 18 years old with CKD stages 2,3 and 4

You may not qualify if:

• CKD stage 5 (eGFR below 15 ).
• Patients with hemolytic anemias.
• Chronic liver diseases .
• Autoimmune diseases.
• Malignancy
• History of blood transfusion last 3 months before the study
• Pregnancy
• Adult polycystic kidney disease ( APCKD)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.

  PMID: 29032957 BACKGROUND

Related Links

• Sood, V., Kamboj, K., Bhatia, P. et al. A randomized trial of once daily versus twice daily dosing of oral iron in CKD. Sci Rep 13, 141 (2023). https://doi.org/10.1038/s41598-022-26589-x

MeSH Terms

Interventions

ferrous sulfate

Study Officials

• Farrag S Mohamed

  Assiut University

  STUDY CHAIR

Central Study Contacts

Farrag S Mohamed, MD

CONTACT

0201064274671; faragsayed99@gmail.com

Youmna Refaat, Professor

CONTACT

yomna-rm@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical physician

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07