NCT02005588

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

November 27, 2013

Last Update Submit

July 27, 2015

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

amino acid chelated ironiron saltiron deficiency anemia

Outcome Measures

Primary Outcomes (1)

  • change in hemoglobin level

    6 months

Secondary Outcomes (2)

  • the occurence of side effects (abdominal colics, constipation, or metallic taste)

    6 months

  • change in serum ferritin level

    6 months

Other Outcomes (1)

  • cost of treatment

    6 months

Study Arms (2)

amino acid chelated iron arm

ACTIVE COMPARATOR

this arm will contain 150 pregnant women with proved iron deficiency anemia and pregnant 14-18 weeks. these pregnant women will be given amino acid chelated iron capsules (15 mg iron/capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules, and hemoglobin 9.1-11 g/dl will receive 1 capsule). complete blood picture and serum ferritin will be assessed at 22-23 weeks, 29-30 weeks and 36-37 weeks. possible side effects (colicky abdominal pains, constipation and metallic taste) will be asked about in each follow up visit.

Drug: amino acid chelated ironDrug: iron salt (ferrous fumarate)

iron salt arm

ACTIVE COMPARATOR

this arm will contain 150 pregnant women with proved iron deficiency anemia and 14-18 weeks gestation. these women will be given oral iron salt ferrous fumarate capsules (350 mg iron/ capsule containing about 70 mg elemental iron/ capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules daily and hemoglobin 9.1-11 g/dl will receive 1 capsule daily. women will be followed up with complete blood picture and serum ferritin at 22-23 weeks, 29-30 weeks and 36-37 weeks. women will be asked about possible side effects (colicky abdominal pains, constipation, and metallic taste) in each visit.

Drug: amino acid chelated ironDrug: iron salt (ferrous fumarate)

Interventions

amino acid chelated ironDRUG

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.

Also known as: ferrotron capsules
amino acid chelated iron armiron salt arm
iron salt (ferrous fumarate)DRUG

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.

Also known as: hemoton capsules
amino acid chelated iron armiron salt arm

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-40 years
  • Pregnant 14-18 weeks
  • Singleton fetus
  • Hb 7-10.9 g/dl
  • Serum ferritin \<12 microgram/L

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine, Cairo University

Cairo, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous fumarate

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ahmed M Sayed, professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology, faculty of medicine, Cairo University

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 9, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

EG(1)