Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB

Obesity Clinical Trial

Official title:

Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB: an Interventional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02569593
• Other study ID #: IAS15
• Secondary ID: s58442
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2015
• Last updated: May 17, 2017
• Start date: October 2015
• Est. completion date: August 2018

Study information

• Verified date: May 2017
• Source: Katholieke Universiteit Leuven
• Contact: Ina Gesquiere
• Phone: 0032 016 37 72 32
• Email: ina.gesquiere[@]pharm.kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).

Description:

Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:

• General information concerning sociodemographic and medical background

• The medical history

• Anthropometric measures

• Physical activity by questionnaire

• Food frequency by questionnaire

• Information about menstrual blood loss.

Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obese patients who have planned a RYGB surgery in the University Hospital Leuven

• Low iron status at the preoperative consultation (ferritin < 30 µg/L and/or transferrin saturation <20%)

Exclusion Criteria:

• Patients with a bariatric surgery history

• Smokers (> 15 cigarettes/day)

• Pregnant women

• Lactating women

• Patients with a positive helicobacter pylori screening

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Iron supplements, more specific Ferrodyn and Vista Ferrum
Ferrodyn is an Fe-chelate supplement. One tablet contains 28 mg elemental iron. Vista Ferrum is an iron(II)sulfate supplement. One tablet also contains 28 mg elemental iron. The volunteers will be asked to take the provided supplement orally with 150 mL of water.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absorption rate from different oral Fe-supplements	The rate and extent of absorption of iron wille be estimated by changes in serum iron concentration.	One year