NCT03830034

Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Detailed description

Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Amino Acid chelated iron tab 15 mg	Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product. Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption. Substances that inhibit absorption such as tannins \& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption. Follow up will be done for all the pregnant women included in our studies at baseline \& then 4, 8 \& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
DRUG	Ferrous Fumarate tab 350 mg( 115 mg elemental iron)	75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb\<9g/dl) this dose can be doubled as recommended by the company of the product. Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption. Substances that inhibit absorption such as tannins \& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption. Follow up will be done for all the pregnant women included in our studies at baseline \& then 4, 8 \& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.

Timeline

• Start date: 2019-02-02
• Primary completion: 2019-10-15
• Completion: 2019-12-01
• First posted: 2019-02-05
• Last updated: 2019-02-05

Locations

1 site across 1 country: Egypt