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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02005588
Other study ID # ferrot2013
Secondary ID nerhado pharmace
Status Completed
Phase Phase 0
First received November 27, 2013
Last updated July 27, 2015
Start date December 2013
Est. completion date July 2015

Study information

Verified date July 2015
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial Summary

Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the investigators are going to compare the efficacy and tolerability of two preparations of oral iron in treatment of iron deficiency anemia with pregnancy.


Description:

In this study, the investigators are going to compare two preparations of oral iron in treatment of iron deficiency anemia with pregnancy. a total of 300 pregnant women will be randomly divided into two equal groups (each containing 150 pregnant woman). one group will receive amino acid chelated iron and the other group will receive iron salt (ferrous fumarate). All pregnant women attending the obstetrics outpatient clinic of kasr al aini hospital at 14-18 weeks gestation will be submitted to complete blood picture and serum ferritin. those who prove to have iron deficiency anemia (hemoglobin less than 11g/dl and serum ferritin less than 12ug/l) will be included in the study. All eligible women will be followed up at 22-23, 29-30 and 36-37 weeks' gestation for the change in hemoglobin level and ferritin level. all women will be also enquired about different side effects during treatment period.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Age: 20-40 years

- Pregnant 14-18 weeks

- Singleton fetus

- Hb 7-10.9 g/dl

- Serum ferritin <12 microgram/L

Exclusion Criteria:

- history of anemia due to other causes as chronic blood loss, hemolytic anemia or thalassemia

- Multiple pregnancy

- known hepatic, renal or cardiovascular abnormality.

- Known peptic ulcer, esophagitis, gastritis or hiatus hernia.

- Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.

- Iron preparation intake within 24 hours of inclusion

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
amino acid chelated iron
the drug will be given to pregnant women 14-18 weeks' gestation who prove to have iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily. for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
iron salt (ferrous fumarate)
this drug will be given to pregnant women 14-18 weeks' gestation with iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily, and for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.

Locations

Country Name City State
Egypt faculty of medicine, Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other cost of treatment 6 months No
Primary change in hemoglobin level 6 months No
Secondary the occurence of side effects (abdominal colics, constipation, or metallic taste) 6 months No
Secondary change in serum ferritin level 6 months No
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Available NCT05151679 - Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy