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PregnancyNCT01071759

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

An observational study of Pregnancy and Helicobacter Pylori Infection, run by E-DA Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
How many people
140 participants
Where
1 siteTaiwan
Study dates
Feb 2009to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Pregnant Ladies

Who may be able to join

  • Pregnant Ladies

Who cannot join

  • Thalassemia

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • E-DA Hospital

    Kaohsiung County

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

    Fu-Chen Kuo, MD, Msc

    Recruiting

Other trials in Taiwan

About this study

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

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.

Keywords
Pregnancy, anemia, Helicobacter pylori, Hemoglobin, Iron, Ferritin
Medical subject headings
Anemia, Iron-Deficiency, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01071759
Study groupRoleWhat they receive
pregnancyNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2010 (estimated)
  2. Study startFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01071759
Sponsor's protocol ID
EDAH-D-97(P)014A
Other IDs
EMRP-097-123
Status last verified
Feb 2010
First submitted
18 Feb 2010
Last updated
19 Feb 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Helicobacter Pylori Infection, run by E-DA Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fu-Chen Kuo, MD, MSc (886-7-6150011 ext. 2981, ed100418@edah.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2010.

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