iron deficiency anemia
Conditions
Interventions
Group I - Combifer-T (Experimental): 5 mL orally 3 times a day, 30 minutes before breakfast, lunch and dinner. The product will be administered from the inclusion in the study and for 3 months.
Group
Iron, Dietary
Dietary Supplements
Tablets
Administration, Oral
Ferrous fumarate,
Combifer,
Trofin
Sponsors
National Center of Bioproducts (BioCen)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 years and over. 2. Patients with pregnancy between 18 and 26 weeks. 3. Pregnant women who meet the diagnostic criteria. 4. Patients with hemoglobin figures between 80 and 109 g/L. 5. Patients who give their consent to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1. Patients with acute gastrointestinal disorders (vomiting, diarrhoea). 2. Patients who received transfusions one month before being included in the study. 3. Known hypersensitivity to any of the components of the formulations. 4. Hemoglobin values less than 80 g/L. 5. Hemochromatosis and/or Hemosiderosis. 6. Lactose intolerant patients. 7. Patients under treatment with iron dextran or who received treatment one month before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin (g/L). Measurement time: At baseline and, every 4 weeks until the end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hematocrit (%). Measurement time: at the beginning and every 4 weeks until the term of pregnancy. 2. Serum iron (µg / dL). Measurement time: at the beginning and every 4 weeks until the term of pregnancy. 3. Reticulocytes (x 10-3). Measurement time: at the beginning and every 4 weeks until the term of pregnancy. 4. Ferritin (ng / mL). Measurement time: at the beginning and every 4 weeks until the term of pregnancy. 5. Transferrin receptor 6. Peripheral lamina (size, shape and color of red blood cells). Measurement time: at the beginning and every 4 weeks until the term of pregnancy. 7. Corpuscuolar constants (Mean Corpuscular Volume (fL), Mean Corpuscular Hemoglobin (pq) and Mean Corpuscular Hemoglobin Concentration (g / L) Measurement time: at the beginning and every 4 weeks until the end of the study. 8. Adverse Events- AE (Occurrence of some AE in the subject (Yes, No); Type of AE (Name of the event); Duration of AE (hours and minutes, days) ; Prior knowledge (Expected, Unexpected); Intensity of the AE (Mild, Moderate, Severe); Consequence of the AE (Serious / serious, Not serious / not serious); Causal relationship (1.Very Probable, 2.Probable, 3. Possible, 4.Unprovable, 5.Not related, 6.Not evaluable); Outcome of the AE (recovered, Not recovered, Recovered with sequelae, Death, Unknown); Attitude regarding the treatment under study (Continuation, Definitive interruption)). Measurement time: for the entire duration of the test. | — |
Countries
Cuba
Contacts
Public ContactNorma Silva Leal
Teaching Gyneco-Obstetric Hospital 10 de Octubre, Daughters of Galicia.
Outcome results
None listed