Effects of Dietary Heme/Non-heme Iron and Helicobacter Pylori (Hp) Infection on Maternal Iron-deficiency Anemia and Fetal Growth Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by E-DA Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01071759
First received: February 18, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

Iron deficiency is considered one of the main nutritional deficiency disorders despite the apparent availability of a high-quality diet even in developed countries, and Iron deficiency anemia (IDA) is the most common form of anemia in the world. IDA during pregnancy has been associated with adverse health consequences for both the mother and her developing fetus. Helicobacter pylori (Hp) may be the most common bacterial infection worldwide, infecting almost half of people in developed countries and 80% of people in developing countries. The available data on the prevalence of Hp infection in Taiwan population was 54.4%. We all know that infection with Hp is strongly associated with peptic ulcer and gastric cancer, but recent evidence suggests that Hp is associated with iron deficiency and anemia, although the mechanisms remain unclear. Till now, only few previous studies specifically have addressed a potential role of Hp infection on anemia or iron deficiency during pregnancy. Our previous Research showed, between the Hp infection (+) and Hp infection (-) gravidas, the associations between the Hp infection and iron deficiency were stronger, although not statistically significant. This might be due to that we needed more cases and evidences to prove the relationship between maternal Hp infection and serum iron, ferritin and hemoglobin levels, or we should further consider the interactions of the particular customs or diet preference of the Taiwanese gravidas. This longitudinal study will recruit 140 women from the antenatal care clinics of E-Da Hospital to examine the association between Hp infection and maternal IDA. The standardized interviews of mothers (anthropometric data, socioeconomic status, medical history, obstetric history, alcohol consumption during pregnancy, and history and duration of iron supplementation during pregnancy) will be conducted, Hp infection status will be determined by the urea breath test and IgG enzyme immunoassay, and the measurement of hemoglobin, iron, and ferritin levels will be obtained 5 times at various antepartum and postpartum points of time during pregnancy (routine prenatal visits of 1st, 2nd, and 3rd trimester, puerperium and 2 weeks after delivery). We hope that we could investigate the possible role of Hp infection in iron deficiency and iron-deficiency anemia during pregnancy in Taiwan, and that early detection and treatment of anemia may reduce the risk of blood transfusion and perinatal and maternal mortality.


Condition
Pregnancy
Helicobacter Pylori Infection
Iron-Deficiency Anemia

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effects of Dietary Heme/Non-heme Iron and Hp Infection on Maternal Iron-deficiency Anemia and Fetal Growth Outcomes - a Perinatal Longitudinal Study

Resource links provided by NLM:


Further study details as provided by E-DA Hospital:

Estimated Enrollment: 140
Study Start Date: February 2009

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant Ladies

Criteria

Inclusion Criteria:

  • Pregnant Ladies

Exclusion Criteria:

  • Thalassemia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01071759

Contacts
Contact: Fu-Chen Kuo, MD, MSc 886-7-6150011 ext 2981 ed100418@edah.org.tw

Locations
Taiwan
E-DA Hospital Recruiting
Kaohsiung County, Taiwan
Contact: Fu-Chen Kuo, MD, MSc    886-7-6150011 ext 2981    ed100418@edah.org.tw   
Principal Investigator: Fu-Chen Kuo, MD, Msc         
Sponsors and Collaborators
E-DA Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01071759     History of Changes
Other Study ID Numbers: EDAH-D-97(P)014A, EMRP-097-123
Study First Received: February 18, 2010
Last Updated: February 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by E-DA Hospital:
Pregnancy
anemia
Helicobacter pylori
Hemoglobin
Iron
Ferritin

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Communicable Diseases
Deficiency Diseases
Helicobacter Infections
Infection
Anemia, Hypochromic
Bacterial Infections
Gram-Negative Bacterial Infections
Hematologic Diseases
Iron Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on October 21, 2014