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The effect of vitamin D administration on treatment of anemia in ESRD patients with vitamin D deficiency on hemodialysis

The effect of vitamin D administration on treatment of anemia in ESRD patients with vitamin D deficiency on hemodialysis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201505152417N17
Enrollment
64
Registered
2016-08-11
Start date
2014-10-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease. End Stage Renal Disease

Interventions

Intervention 1: Intervention group: Pearl vitamin D 50000 IU, weekly for 12 weeks and after 3 weeks, manufactured by Zahravi company. Intervention 2: Control group: Pearl placebo, weekly for 12 weeks
Treatment - Drugs
Placebo
Intervention group: Pearl vitamin D 50000 IU, weekly for 12 weeks and after 3 weeks, manufactured by Zahravi company
Control group: Pearl placebo, weekly for 12 weeks and after 3 weeks, manufactured by Zahravi company

Sponsors

Vice Chancellor for Research, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with renal failure on hemodialysis for 3 months at least; Patients with hemoglobin concentration Lower than 12 g/dl; Patients with vitamin D deficiency (25(OH) vit D < 30 ng/ml); Exclusion criteria: Patients with serum calcium level more than 9.5mg/dL; Patients with serum Phosphate level more than 5.5mg/dL; Non-compliant patients; Patients who were treated by medications that could affect their Hb level such as immunosuppressants.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum 25 OH vitamin D level. Timepoint: At begining, end of 2 and 4 months. Method of measurement: ELISA, ng/mL.;Serum ferritin level. Timepoint: Monthly. Method of measurement: ELISA, mg/dL.;Serum Hemoglobin level. Timepoint: Monthly. Method of measurement: Cell counter, g/dL.;Erythropoietin dose requirement. Timepoint: Weekly. Method of measurement: Mathematically.

Secondary

MeasureTime frame
Serum calcium level. Timepoint: Monthly. Method of measurement: ELISA, mg/dL.;Serum albumin level. Timepoint: Monthly. Method of measurement: ELISA, g/dL.;Serum adiponectin level. Timepoint: Begining and after 4 months. Method of measurement: ELISA.;Serum leptin level. Timepoint: Begining and after 4 months. Method of measurement: ELISA.;Serum ICAM level. Timepoint: Begining and after 4 months. Method of measurement: ELISA.;Serum VCAM level. Timepoint: Begining and after 4 months. Method of measurement: ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Firouzeh Moeinzadeh

Isfahan University of Medical Sciences

moinzade@resident.mui.ac.ir+98 31 3620 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026