Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858505
• Other study ID #: IDAT
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2016
• Last updated: August 3, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. During pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass.

Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman needs about 1000 mg of iron during pregnancy.

Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further Iron deficiency anemia.

Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting.

Iron amino acid chelates have been emerged to be used as agents for prevention and treatment of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects.

Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. The iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• twin gestations

• ±12 weeks)

• normal hemoglobin level (Hb = 120 g/L).

• women were living in nearby area to make up follow up quit possible

• willing to participate in our study

Exclusion Criteria:

• a recent blood transfusion

• threatened miscarriage

• pathological blood loss

• vegetarian diet

• intolerant to oral iron form

• history of haematologic disorder

• chronic diseases

• unwillingness to co-operate.

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• 27 mg elemental iron

• 54 mg elemental iron

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level		24 weeks	Yes