CONTROLLED STUDY OF FERROUS POLYMOTHERATE VS. FERROUS SULPHATE IN THE TREATMENT OF FERROPENIC ANEMIA IN CHILDREN FROM 6 MONTHS TO TWO YEARS.

Not Applicable

• Conditions: -D50 Iron deficiency anaemia; Iron deficiency anaemia; D50

• Registration Number: PER-041-04
• Lead Sponsor: ABL PHARMA PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Acceptance by the parents or legal guardians of the child documented with signing the corresponding informed consent form.
2. Have an age between 6 months and 2 years
3. Hemoglobin> 8 and <11 g / dl and / or decreased serum Ferritin.
4. Have the possibility of attending the consultation according to the schedule of study.
5. Be included between the percentiles 10-90, age-statural for age and
sex according to the tables of the NCHS.

Exclusion Criteria

1. History of intolerance to iron salts
2. History of chronic anemia resistant to treatment
3. Acute pathologies (e.g., acute infections) or chronic diseases (e.g.
intestinal absorption) that can modify the blood values
4. Intestinal parasitic diseases detected by simple parasitological examination at the beginning of the study.
5. Need to use drugs that can modify the hematological values (e.g., prolonged use of AMEs, steroids in the last 3 months, cytostatics)
6. History of blood dyscracies
7. History of liver or kidney pathology

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Percentage of patients who complete their participation twelve weeks after the start of the study<br>Measure:Percentage of patients who complete their participation twelve weeks after the start of the study<br>Timepoints:12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Percentage of patients who are withdrawn from the study due to adverse reactions.<br>Measure:Percentage of patients who are withdrawn from the study due to adverse reactions.<br>Timepoints:12 weeks<br>