CLINICAL TRIAL, DOUBLE-BLIND AND RANDOMIZED, TO EVALUATE THE EFFICACY AND SAFETY OF THE FERANIN®? FOL 1000 COMPLEX (FERRIC HYDROXIDE POLYMALTOSATE 100MG + FOLIC ACID 1000UG AT A COMBINED FIXED DOSE) COMPARED WITH FERROUS SULFATE (120MG OF ELEMENTAL IRON) + FOLIC ACID 800UG ADMINISTERED SEPARATELY, ON ANEMIA DURING PREGNANCY.

Phase 3

• Conditions: O990 Anaemia complicating pregnancy, childbirth and the puerperium; Anaemia complicating pregnancy, childbirth and the puerperium; O990

• Registration Number: PER-028-22
• Lead Sponsor: QUIMICA SUIZA SOCIEDAD ANONIMA CERRADA - QUIMICA SUIZA S.A.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1. Pregnant participants in the 1st trimester of pregnancy (start of gestation through 12 weeks) who are 18 years of age or older.

2. With a diagnosis of iron deficiency anemia (Hb concentration <11g/dl and serum ferritin concentration <20 µg/L).

3. Be able to understand, sign and date an informed consent document according to the guidelines of good clinical practice and local regulations.

4. Consent signed and dated by the father of the conceived except death, irrefutable impossibility, loss of rights in accordance with current regulations.

5. Commitment to comply with assigned treatment and tests.

6. Desire to adhere to the treatment and follow-up program.

Exclusion Criteria

1. Participantes embarazadas en el 2do y/o 3er trimestre mayores y/o menores de 18 años que tengan o esten recibiendo prescripcion medica para tratamiento de Deficiencia de Hierro durante el embarazo.

2. Sobrecarga de hierro en el cuerpo (hemocromatosis, hemolisis cronica).

3. Alteraciones en el uso del hierro (anemia por plomo, anemia sideroacretica), Talasemia.

4. Anemia megaloblastica, por insuficiencia de vitamina B12.

5. En casos de anemia infecciosa.

6. Antecedentes de anemia relacionada con enfermedades cronicas (cancer o alguna otra enfermedad cronica).

7. Antecedentes de anemia por hemorragia gastrointestinal, enfermedades autoinmunes, hepaticas o renales.

8. Hipersensibilidad al polimaltosato de hierro.

9. Anemia no ferropenica.

10. Hipersensibilidad al acido folico.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood test<br> NAME OF THE RESULT: Change in Hemoglobin values (g/dL)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Evaluation from the beginning (day 0) until days 60 and 90 after starting treatment.