Condition category
Infections and Infestations
Date applied
14/12/2009
Date assigned
06/01/2010
Last edited
06/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel López de Romaña

ORCID ID

Contact details

Avenida El Libano 5524
Macul
Santiago
7830489
Chile

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Fondecyt 1080032

Study information

Scientific title

Effect of Helicobacter infection on zinc and iron absorption: a single blind randomised controlled trial

Acronym

Study hypothesis

1. Helicobacter pylori infection will have a negative effect on zinc absorption of adults who consume a wheat product fortified with iron and zinc
2. Zinc absorption from a wheat product fortified with zinc oxide will be significantly lower than that from the same product fortified with zinc sulfate in adults with Helicobacter pylori infection
3. Helicobacter pylori infection will have a negative effect on iron absorption of adults who consume a wheat product fortified with iron and zinc
4. Iron absorption from a wheat product fortified with ferrous fumarate will be significantly lower than that from the same product fortified with ferrous sulfate in adults with Helicobacter pylori infection
5. Iron and zinc absorption will be significantly lower in adults with hypochlorhydria compared to those with normal gastric acidity

Ethics approval

University of Chile, Institute of Nutrition and Food Technology (INTA) approved on the 20th June 2007 (ref: approval act No. 7)

Study design

Randomised controlled single-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Helicobacter pylori infection

Intervention

The urea-C13 breath test will be used to assess Helicobacter pylori (HP) infection. A questionnaire will be used to determine gastrointestinal symptoms and all volunteers who indicate having symptoms will be excluded from the study.

Day 1:
Subjects will provide a fasting urine sample, which will be used as the baseline sample for zinc stable isotope enrichment analysis and as pre-intake sample for gastric pH measurement. Afterwards, they will randomly receive 100 g of bread fortified with either 5.5 mg of ferrous fumarate and 6 mg of zinc oxide or 5.5 mg of ferrous sulfate and 6 mg of zinc sulfate. Bread fortified with ferrous fumarate and zinc oxide will be labelled with 3 µCi of radioisotope 55Fe and 0.5 mg of stable isotope 67Zn and bread fortified with ferrous sulfate and zinc sulfate will be labelled with 1 µCi of radioisotope 59Fe and 0.25 mg of stable isotope 70Zn. A urine sample will be collected after breakfast consumption for gastric pH measurement.

Day 2:
Subjects will receive for breakfast the same bread they received on day 1 but labelled only with a stable isotope of zinc. Total dose of 67Zn for 2 days of study will be 1 mg and total dose of 70Zn for 2 days of study will be 0.5 mg. An additional 0.25 mg of zinc will be added to bread labelled with 70Zn to maintain the dose effect of the isotope constant.

Day 3:
A 20 ml fasting blood sample will be collected to determine hemoglobin, serum iron, TIBC, transferrin saturation, serum ferritin, serum zinc, high sensitivity c-reactive protein, pepsinogen I and pepsinogen II concentrations. A 1 mg dose of stable isotope 68Zn, as sulfate, will be administered intravenously immediately after blood colection. Subjects will receive for breakfast 100 g of bread fortified with those salts they did not receive on Days 1 - 2 and labelled with corresponding iron and zinc isotopes.

Day 4:
Subjects will receive for breakfast the same bread they received on Day 3 but labelled only with a stable isotope of zinc.

Days 7 - 11:
50 ml urine samples will be collected each morning and afternoon for zinc stable isotope enrichment analysis.

Day 17:
A second 20 ml blood sample will be obtained to assess circulating iron radioactivity.

Days 18 - 23:
Subjects will receive daily a proton pump inhibitor (20 mg/d omeprazole). 50 ml urine samples will be collected each morning and afternoon of Days 21 - 23 for zinc stable isotope enrichment analysis.

Day 24:
Subjects will provide a fasting urine sample, which will be used as the baseline sample for zinc stable isotope enrichment analysis and as pre-intake sample for gastric pH measurement. Furthermore, 20 ml of blood will be obtained to assess circulating iron radioactivity and ultrasensitive c-reactive protein, pepsinogen I and pepsinogen II concentrations. A 1 mg dose of stable isotope 68Zn, as sulfate, will be administered intravenously immediately after blood collection. Subsequently, all subjects will receive 100 g of bread fortified with 5.5 mg of iron, as ferrous fumarate, and 6 mg of zinc, as zinc oxide, labelled with 3 µCi of radioisotope 55Fe and 0.5 mg of stable isotope 67Zn. A urine sample will be collected after breakfast consumption for gastric pH measurement.

Day 25:
Subjects will receive for breakfast the same bread they received on Day 21 but labelled only with a stable isotope of zinc.

Days 28 - 32:
50 ml urine samples will be collected each morning and afternoon for zinc stable isotope enrichment analysis.

Day 38:
20 ml of blood will be collected to assess circulating iron radioactivity.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ferrous sulfate, zinc sulfate, ferrous fumarate, zinc oxide

Primary outcome measures

Assessed on days 17 and 38 of the study:
1. Fractional iron absorption, assessed by Eakins and Brown's double-isotope technique
2. Fractional zinc absorption, determined from the ratio of urinary enrichment of oral doses (67Zn and 70Zn) as a proportion of urinary enrichment of intravenous dose (68Zn)

Secondary outcome measures

1. Intragastric pH, assessed by the urine acid output test, assessed on days 1 and 24 of the study
2. Pepsinogen I and pepsinogen II will be determined by radioimmunoassay, assessed on day 3 of the study. Haemoglobin, serum iron, TIBC and transferrin saturation, serum ferritin and serum zinc, assessed on day 3 of the study
7. High sensitivity C-reactive protein, assessed on day 3 of the study

Overall trial start date

01/04/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asymptomatic adults
2. Aged 35 - 45 years (women) and aged 25 - 45 years (men)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant exclusion criteria

Gastrointestinal symptoms

Recruitment start date

01/04/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Chile

Trial participating centre

Avenida El Libano 5524
Santiago
7830489
Chile

Sponsor information

Organisation

University of Chile, Institute of Nutrition and Food Technology (INTA) (Chile)

Sponsor details

Avenida El Libano 5540
Macul
Santiago
7830489
Chile

Sponsor type

University/education

Website

http://www.inta.cl

Funders

Funder type

Government

Funder name

Fund for Scientific and Technological Chile (Fondo de Desarrollo Científico y Tecnológico [FONDECYT]) (Chile) (ref: 1080032)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes