Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women

Iron Deficiency Anemia Clinical Trial

Official title:

Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815449
• Other study ID #: FDS-SAV-2103
• Status: Completed
• Phase: N/A
• First received: May 24, 2016
• Last updated: July 31, 2017
• Start date: May 8, 2017
• Est. completion date: July 24, 2017

Study information

• Verified date: July 2017
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this.

In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context of a Nigerian meal in women.

24 Female subjects with low serum ferritin levels will be included in the study. The study will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The absorption of iron will be evaluated after every period and compared between the cubes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 24, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy female Nigerian subjects;

• Age > 18 and <40 years at screening;

• Body weight <65 kg;

• Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);

• With iron deficiency judged by a serum ferritin concentration of <15µg/L;

• Reported intense sporting activities = 10h/w;

• Reported alcohol consumption = 14 units/w;

• Willing and able to participate in the study;

• Having given a written informed consent.

Exclusion Criteria:

• Being an employee of Unilever or the Department of Family, Nutrition and Consumer Science of the Obafemi Alowolo University;

• Blood donation or significant blood loss over the past 6 months;

• Being severely anemic (hemoglobin < 8.0 g/dL)

• Reported use of any medically- or self-prescribed diet;

• Use of vitamin or mineral supplements and unwillingness to discontinue their use one week prior the study and during the study;

• Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;

• Is pregnant or will be planning pregnancy during the study period;

• Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;

• Known gastrointestinal (including helminth infection) or metabolic disorders;

• Participation in another clinical trial during the last 30 days prior to the beginning of the study;

• Symptomatic malaria (no blood smear analyses on malaria required)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Other:
• Meals prepared with iron fortified cube with Low stabilizer level
Meals prepared with iron fortified cube with Low stabilizer level
• Meals prepared with iron fortified cube with Medium stabilizer level
Meals prepared with iron fortified cube with Medium stabilizer level
• Meals prepared with iron fortified cube with High stabilizer level
Meals prepared with iron fortified cube with High stabilizer level

Locations

Country	Name	City	State
Nigeria	Obafemi Owalowo University	Ile Ife

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Obafemi Awolowo University

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron isotopic composition of the blood at the end of each intervention period	The amount of iron isotopic label in the blood will be related to the low, medium and high stabilizer level in the cubes to determine whether a dose-response relationship exists.	16 days
Secondary	Iron isotopic composition of the blood	The amount of iron isotopic label in the blood at the end of each administration period plus 14 day incorporation time will be used to calculate the absolute Iron absorption for each stabilizer level	1, 22, 43 and 64 days