Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia

NCT06631612 | Active Not Recruiting Phase 4

• 1 other identifier: FMASU MD288/2023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if giving iron supplementation every other day is as effective as giving it daily in children with Iron Deficiency Anemia. The main questions it aims to answer are:

1. 1.Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose?
2. 2.Which group will suffer less side effects from Iron Supplementation?

Conditions

Iron Deficiency Anemia Treatment

Keywords

iron defiiency; Anemia; hepcidin

Outcome Measures

Primary Outcomes (4)

• change in hemoglobin

  treatment will be considered successful if there is an increase of hemoglobin at least 1 g/dl every 4 weeks

  8 weeks

• change in Iron Profile

  changes in serum Iron will be compared between the two groups

  8 weeks

• change in iron profile

  change in TIBC will be compared between the two groups

  8 weeks

• change in iron profile

  change in transferrin saturation will be compared between the two groups

  8 weeks

Secondary Outcomes (1)

• frequency of side effects

  8 weeks

Study Arms (2)

daily dose of Iron Supplementation

ACTIVE COMPARATOR

daily dose of 3 mg/kg elemental Iron before bed

Drug: ferric hydroxide polymaltose complex; Drug: Albendazole.

alternate day regimen

EXPERIMENTAL

every other day dose of 3mg/kg elemental Iron before bed

Drug: ferric hydroxide polymaltose complex; Drug: Albendazole.

Interventions

ferric hydroxide polymaltose complex DRUG

participants will receive oral iron supplementation according to body weight every other day

alternate day regimen

Albendazole. DRUG

both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week

alternate day regimen; daily dose of Iron Supplementation

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 2-12 years of age diagnosed wit Iron Deficiency anemia according to WHO criteria (hemoglobin below 11 g/dl and transferrin saturation below 16%)

You may not qualify if:

• Children already being treated for iron deficiency anemia
• Children known to have hemolytic anemias
• Children with GIT disorders that prevent iron absorption (Inflammatory bowel disease,celiac disease …etc)
• Children with chronic diseases (heart disease,liver disease,kidney disease, endocrinological disease).
• Children who are underweight or morbidly obese

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abaseya, Egypt

Location

MeSH Terms

Conditions

Anemia

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wessam A Professor, MD

  Ain Shams Pediatrics Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: start date: June 2025 end date: June 2026
• Access Criteria: Anyone can access the IPD plan including the excel sheet of data collection and what type of analysis was used.

Locations

EG (1)