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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-041-04
Enrollment
Unknown
Registered
2004-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

ferrous sulfate Type of group
A concentration of elemental iron of 15 mg in 0.6 ml of a calibrated dropper is administered. Group name:FERRIC POLYMALTHOSATE Type of group
A concentration of elemental iron of 50mg / mL is administered (dropper of 1ml = 20 drops)

Sponsors

ABL PHARMA PERU,
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
Outcome name:Percentage of patients who are withdrawn from the study due to adverse reactions. Measure:Percentage of patients who are withdrawn from the study due to adverse reactions. Timepoints:12 weeks

Primary

MeasureTime frame
Outcome name:Percentage of patients who complete their participation twelve weeks after the start of the study Measure:Percentage of patients who complete their participation twelve weeks after the start of the study Timepoints:12 weeks

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)