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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list