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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071759
Recruitment Status : Unknown
Verified February 2010 by E-DA Hospital.
Recruitment status was:  Recruiting
First Posted : February 19, 2010
Last Update Posted : February 19, 2010
Information provided by:
E-DA Hospital

Brief Summary:
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 or disease
Pregnancy Helicobacter Pylori Infection Iron-Deficiency Anemia

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Study Type : Observational
Estimated Enrollment : 140 participants
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
Study Start Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Ladies

Inclusion Criteria:

  • Pregnant Ladies

Exclusion Criteria:

  • Thalassemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071759

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Contact: Fu-Chen Kuo, MD, MSc 886-7-6150011 ext 2981

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E-DA Hospital Recruiting
Kaohsiung County, Taiwan
Contact: Fu-Chen Kuo, MD, MSc    886-7-6150011 ext 2981   
Principal Investigator: Fu-Chen Kuo, MD, Msc         
Sponsors and Collaborators
E-DA Hospital
Layout table for additonal information Identifier: NCT01071759    
Other Study ID Numbers: EDAH-D-97(P)014A
EMRP-097-123 ( Other Identifier: E-DA Hospital )
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010
Keywords provided by E-DA Hospital:
Helicobacter pylori
Additional relevant MeSH terms:
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Communicable Diseases
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders