Revisions for Combifer-T, Trofin and Ferrous Fumarate in iron-deficiency anemia in pregnant women. | Registro Público Cubano de Ensayos Clínicos

--- 8 March 2021 - 5:17pm by BIOCEN
+++ 8 March 2021 - 5:21pm by BIOCEN
-Combifer T, Trofin and Ferrous Fumarate in iron-deficiency anemia in pregnant women.
+Combifer-T, Trofin and Ferrous Fumarate in iron-deficiency anemia in pregnant women.
--12-31 00:00:00
+-05-24 00:00:00
-Hemoglobin (g/L). Measurement time: At baseline and, every 4 weeks until the end of pregnancy.
+Hemoglobin (g/L). Measurement time: At baseline and, every 4 weeks until the end of study.
-. Hematocrit (%). Measurement time: At baseline and, every 4 weeks until the end of pregnancy.
+. Hematocrit (%). Measurement time: at the beginning and every 4 weeks until the term of pregnancy.
-. Serum iron (μg / dL). Measurement time: At baseline and, every 4 weeks until the end of pregnancy.
+. Serum iron (μg / dL). Measurement time: at the beginning and every 4 weeks until the term of pregnancy.
-. Reticulocytes (x 10-3). Measurement time: At baseline and, every 4 weeks until the end of pregnancy.
+. Reticulocytes (x 10-3). Measurement time: at the beginning and every 4 weeks until the term of pregnancy.
-. Ferritin (ng/mL). At baseline and, every 4 weeks until the end of pregnancy.
+. Ferritin (ng / mL). Measurement time: at the beginning and every 4 weeks until the term of pregnancy.
-. Peripheral lamina (size, shape and color of red blood cells). Measurement time At baseline and, every 4 weeks until the end of pregnancy.
+. Transferrin receptor
-. Average Corpuscular Volume (fL). Measurement time: At baseline and, every 4 weeks until the end of pregnancy.
+. Peripheral lamina (size, shape and color of red blood cells). Measurement time: at the beginning and every 4 weeks until the term of pregnancy.
-. Corpuscular Media Hemoglobin (pq). Measurement time: At baseline and, every 4 weeks until the end of pregnancy.
+. 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.
-. Concentration of Corpuscular Hemoglobin Medium (g/L). At baseline and, every 4 weeks until the end of pregnancy.
+. 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.
-. Adverse Events-AE (Occurrence of some AE in the subject (Yes, No); Type of AE (Name of the adverse event); Time of appearance (Immediate, Mediate, Delayed); Duration of the AE (hours and minutes, days); Prior knowledge (Expected, Unexpected); Intensity of the AE (Mild, Moderate, Severe); Consequence of the AE (Serious, Not serious); Causality Relationship (1. Very likely, 2. Probable, 3. Possible, 4. Not likely, 5. Not related, 6. Not evaluable); Result of the AE (Recovered, Not Recovered, Recovered with squeals, Death, Unknown); Attitude regarding the treatment under study (Continuation, Definitive interruption)). Measurement time: each administration of the product and during the entire duration of the test.
-Group I - Combifer (Experimental): a tablet of Combifer (500mg) by oral route 3 times a day, 30 minutes before breakfast, lunch and dinner. The tablets will be administered from enrollment in the study until the end of pregnancy.
+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 II - Trofin (Control): A tablespoon of Trofin (15mL) by oral route 3 times a day, 30 minutes before breakfast, lunch and dinner. The medication will be administered from enrollment in the study until the end of pregnancy.
+Group II -Trofin (Control): 1 tablespoon Trofin (15mL) orally 3 times a day, 30 minutes before breakfast, lunch and dinner. The product will be administered from inclusion in the study and for 3 months.
-Group III - Ferrous Fumarate (Control): A tablet of Ferrous Fumarate (200mg) by oral route 2 times a day, 30 minutes after breakfast and lunch. The tablets will be administered from enrollment in the study until the end of pregnancy.
+Group III - Ferrous fumarate (Control): 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.
 years
-. Patients who have given their informed consent to participate in the trial.
+. Pregnant women aged 18 years and over.
-. Patients with pregnancy between 15 and up to 24 weeks of gestation.
+. Patients with pregnancy between 18 and 26 weeks.
-. Patients with hemoglobin levels between 75 and 109 g/L.
+. Pregnant women who meet the diagnostic criteria.
+. Patients with hemoglobin figures between 80 and 109 g / L.
+. Patients who give their consent to participate in the study in writing.
+Resultados de traducción
 . Patients with acute gastrointestinal disorders (vomiting, diarrhea).
-. Patients who received transfusions during pregnancy.
+. Patients who received transfusions one month before being included in the study.
-. Pregnant women with hypertension who have indicated Methyldopa since Ferrous Fumarate reduces the hypotensive effect of Methyldopa.
+. Known hypersensitivity to any of the components of the formulations.
-. Patients under treatment with iron dextran or who received treatment one month before the start of the study.
+. Hemoglobin values less than 80 g / L.
+. Hemochromatosis and / or Hemosiderosis.
+. Lactose intolerant patients.
+. Patients under treatment with iron dextran or who received treatment one month before the start of the study.
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+-02-28T00:00:00
+-04-29T00:00:00
-Evaluation of the efficacy and safety of Combifer T compared to Trofin and Ferrous fumarate in the treatment of iron deficiency anemia in pregnant women.
+Evaluation of the efficacy and safety of Combifer-T compared to Trofin and Ferrous fumarate in the treatment of iron deficiency anemia in pregnant women.

Combifer-T, Trofin and Ferrous Fumarate in iron-deficiency anemia in pregnant women.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the efficacy and safety of Combifer-T compared to Trofin and Ferrous fumarate in the treatment of iron deficiency anemia in pregnant women.

Secondary indentifying numbers:

GEC2019CBF021

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BioCen)

Source(s) of monetary or material support:

National Center of Bioproducts (BioCen)Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Norma

Last name:

Silva Leal

Medical Specialty :

Specialist of second degree in Gynecology and Obstetrics, Consultant Professor. MsC Integral Care for Women

Affiliation:

Docent Gyneco-Obstetric Hospital 10 de Octubre, Daughters of Galicia.

Postal address:

Our Lady of Rule No. 52 between Remedios and Quiroga, Luyano. October 10th.

City:

Havana

Country:

Cuba

Zip Code:

10500

Telephone:

+53-76967168

Email address:

hijasgal@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Mother House "Leonor Perez Cabrera", Yeilin Pereira Minnoz, MD , Specialist of first Degree in Gynecology and Obstetric.

Havana, Docent Gyneco-Obstetric Hospital America Arias Yuribet Borges Moreno, MD, Specialist of first Degree in Hematology.

Research ethics committees:

Docent Gyneco-Obstetric Hospital 10 de Octubre, Daughters of Galicia, in review.

Mother House “Leonor Perez Cabrera” , in review.

Docent Gyneco-Obstetric Hospital America Arias , in review.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

24/05/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Anemia

Health condition(s) code:

Hematinics

Anemia

Hematologic Diseases

Hemic and Lymphatic Diseases

Iron Deficiency

Intervention(s):

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 II -Trofin (Control): 1 tablespoon Trofin (15mL) orally 3 times a day, 30 minutes before breakfast, lunch and dinner. The product will be administered from inclusion in the study and for 3 months. Group III - Ferrous fumarate (Control): 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.

Intervention code:

Iron, Dietary

Biological Products

Dietary Supplements

Tablets

Administration, Oral

Intervention keyword:

Ferrous fumarate, Combifer, Trofin

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Hemoglobin (g/L). Measurement time: At baseline and, every 4 weeks until the end of study.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

None

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:

Resultados de traducción 1. Patients with acute gastrointestinal disorders (vomiting, diarrhea). 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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

120

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Norma

Last Name:

Silva Leal

Specialty:

Specialist of second Degree in Gynecology and Obstetrics, Consultant Professor. MsC Integral Care for Women

Affiliation:

Teaching Gyneco-Obstetric Hospital 10 de Octubre, Daughters of Galicia.

Postal Address:

52 Our Lady of Rule between Remedios and Quiroga, Luyano. October 10th.

City:

Havana

Country:

Cuba

Zip Code:

10500

Telephone:

+53-76967168

Email :

hijasgal@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Suset

Last Name:

Rodriguez Chavez

Specialty:

BSc. Pharmaceutic Science

Affiliation:

National Center of Bioproducts, BioCen

Postal Address:

Road to Beltran Km 1 ½, Bejucal

City:

Mayabeque

Country:

Cuba

Zip Code:

32600

Telephone:

+53-47682201-07 ext 1145 and 1147

Email :

suset.rdguez@biocen.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/12/2021

Date of available results:

28/02/2022

Date of first publication:

29/04/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000296

Date of Registration in Primary Registry:

14/01/2019

Record Verification Date:

2021/03/08

Next update date:

2022/03/08

Link to the spanish version:

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Combifer-T, Trofin and Ferrous Fumarate in iron-deficiency anemia in pregnant women.

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