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

NCT ID: NCT02815449

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2017-07-24

Brief 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.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Low stabilizer level

Meals prepared with iron fortified cube with low stabilizer level

Group Type: EXPERIMENTAL

Meals prepared with iron fortified cube with Low stabilizer level

Intervention Type: OTHER

Meals prepared with iron fortified cube with Low stabilizer level

Medium stabilizer level

Meals prepared with iron fortified cube with medium stabilizer level

Group Type: EXPERIMENTAL

Meals prepared with iron fortified cube with Medium stabilizer level

Intervention Type: OTHER

Meals prepared with iron fortified cube with Medium stabilizer level

High stabilizer level

Meals prepared with iron fortified cube with high stabilizer level

Group Type: EXPERIMENTAL

Meals prepared with iron fortified cube with High stabilizer level

Intervention Type: OTHER

Meals prepared with iron fortified cube with High stabilizer level

Interventions

Meals prepared with iron fortified cube with Low stabilizer level

Meals prepared with iron fortified cube with Low stabilizer level

Intervention Type: OTHER

Meals prepared with iron fortified cube with Medium stabilizer level

Meals prepared with iron fortified cube with Medium stabilizer level

Intervention Type: OTHER

Meals prepared with iron fortified cube with High stabilizer level

Meals prepared with iron fortified cube with High stabilizer level

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Obafemi Awolowo University

OTHER

Sponsor Role: collaborator

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Funke Olumakaiye, PhD

Role: PRINCIPAL_INVESTIGATOR

Obafemi Awolowo University

Locations

Obafemi Owalowo University

Ile-Ife, , Nigeria

Countries

Nigeria

References

Eilander A, Funke OM, Moretti D, Zimmermann MB, Owojuyigbe TO, Blonk C, Murray P, Duchateau GS. High Bioavailability from Ferric Pyrophosphate-Fortified Bouillon Cubes in Meals is Not Increased by Sodium Pyrophosphate: a Stable Iron Isotope Study in Young Nigerian Women. J Nutr. 2019 May 1;149(5):723-729. doi: 10.1093/jn/nxz003.

Reference Type: DERIVED

PMID: 31004134 (View on PubMed)

Other Identifiers

FDS-SAV-2103

Identifier Type: -

Identifier Source: org_study_id