Effectiveness of Oral Iron Therapy in Iron Deficiency Ane... | NCT07267975

Studies
Effectiveness of Oral Iron Therapy in Iron Deficiency Anemia With Daily vs Alternate Day Dosing

NCT07267975

Sponsor

University of Child Health Sciences and Children's Hospital, Lahore

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Iron Deficiency Anemia
Iron Deficiency Anemia Treatment

Interventions

Ferrous sulphate
Ferrous sulphate

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2025Actual

Primary Completion Date

Mar 7, 2025Actual

Completion Date

May 7, 2025Actual

First Submitted Date

Nov 24, 2025

First Submission Date that Met QC Criteria

Nov 24, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2026

Last Update Posted Date

Jun 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marryam Kaleem, Post graduate resident, University of Child Health Sciences and Children's Hospital, LahorePrincipal Investigator

Lead Sponsor

University of Child Health Sciences and Children's Hospital, LahoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Treating iron deficiency anemia in children with daily and alternate day oral iron therapy

Detailed Description

Comparison of effectiveness of oral iron in daily and alternate group in children

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continuous oral iron therapy	Active Comparator	Oral iron daily dosing 6mg/kg/day	Drug: Ferrous sulphate
Intermittent oral iron	Experimental	Oral iron therapy on alternate day with dose of 6mg /kg/day for 3 mons	Drug: Ferrous sulphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ferrous sulphate	Drug	Continuous vs intermittent oral iron therapy to see the difference of Hemoglobin rose in both group	Continuous oral iron therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rise in hemoglobin level after oral iron	Hemoglobin level change in g/dl	3 months
Change in Hemoglobin level	Hb rise in g/dl	3month

Secondary Outcomes

Measure	Description	Time Frame
Rise in ferritin level	Ferritin level change in ng/ml	3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both genders with ages in the range of 0 -60 months suffering from IDA as per operational definition.

Exclusion Criteria:

Who have already taken treatment for IDA during last 2-months as per history/clinical record.
Who have undergone recent blood transfusion during last 12-weeks as per history/clinical record.
Children with chronic kidney disease, chronic liver disease, cardiac failure or concomitant malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of child health science and the children hospital lahore		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Confidentiality

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C020748	ferrous sulfate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided