Treatment of Iron Deficiency Anemia With Pregnancy

Iron Deficiency Anemia of Pregnancy Clinical Trial

Official title:

Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy

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

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia of Pregnancy

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