Skip to main content
OpenTrials
Completed

NCT Number: NCT02858505

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

27 mg elemental iron

Drug

54 mg elemental iron

Drug

Primary outcomes

  1. Hemoglobin level

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.