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

NCT03830034 | Unknown Phase 4 DMC

• 1 other identifier: IDA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Hemoglobine (Hb) Rise

  follow up CBC after 12 weeks of treatment given

  after 12 weeks of treatment.

Secondary Outcomes (2)

• Hemoglobine (Hb) Rise

  after 4,8 weeks of treatment.

• Adverse effects of the medication given

  3months

Study Arms (2)

Amino Acid chelated iron tab 15 mg group

EXPERIMENTAL

Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product).

Drug: Amino Acid chelated iron tab 15 mg

Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group

ACTIVE COMPARATOR

Contain 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.

Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron)

Interventions

Amino Acid chelated iron tab 15 mg DRUG

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.

Also known as: Ferrotron

Amino Acid chelated iron tab 15 mg group

Ferrous Fumarate tab 350 mg( 115 mg elemental iron) DRUG

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.

Also known as: Haemacaps

Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: this trial conducted on treatment of iron deficiency anemia in pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
• Hemoglobin level 8-10.5 g/dL
• Serum ferritin\<15µg/L

You may not qualify if:

• The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect…).
• Multiple gestations
• The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
• Patients with known gastritis
• History of mal-absorption syndrome
• Those with known hypersensitivity to iron preparations
• Those under current iron supplementation

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university maternity hospital

Cairo, 25187, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous fumarate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ahmed Elshahawy, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Elshahawy, MD

CONTACT

+01223266380; ahmedshafy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 5, 2019
• Study Start: February 2, 2019
• Primary Completion: October 15, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

EG (1)