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

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Not Applicable

Locations

Nigeria

Study Type

Interventional

Intervention

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 High stabilizer level

About this trial

This is an interventional other trial for Iron Deficiency Anemia focused on measuring Iron fortification, Bioavailability, Nigeria, Women, Bouillon cubes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Obafemi Owalowo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low stabilizer level

Medium stabilizer level

High stabilizer level

Arm Description

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 high stabilizer level

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02815449

First Posted

May 24, 2016

Last Updated

July 31, 2017

Sponsor

Unilever R&D

Collaborators

Obafemi Awolowo University

1. Study Identification

Unique Protocol Identification Number

NCT02815449

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

May 8, 2017 (Actual)

Primary Completion Date

July 24, 2017 (Actual)

Study Completion Date

July 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unilever R&D

Collaborators

Obafemi Awolowo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

Iron fortification, Bioavailability, Nigeria, Women, Bouillon cubes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low stabilizer level

Arm Type

Experimental

Arm Description

Meals prepared with iron fortified cube with low stabilizer level

Arm Title

Medium stabilizer level

Arm Type

Experimental

Arm Description

Meals prepared with iron fortified cube with medium stabilizer level

Arm Title

High stabilizer level

Arm Type

Experimental

Arm Description

Meals prepared with iron fortified cube with high stabilizer level

Intervention Type

Other

Intervention Name(s)

Meals prepared with iron fortified cube with Low stabilizer level

Intervention Description

Meals prepared with iron fortified cube with Low stabilizer level

Intervention Type

Other

Intervention Name(s)

Meals prepared with iron fortified cube with Medium stabilizer level

Intervention Description

Meals prepared with iron fortified cube with Medium stabilizer level

Intervention Type

Other

Intervention Name(s)

Meals prepared with iron fortified cube with High stabilizer level

Intervention Description

Meals prepared with iron fortified cube with High stabilizer level

Primary Outcome Measure Information:

Title

Iron isotopic composition of the blood at the end of each intervention period

Description

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.

Time Frame

16 days

Secondary Outcome Measure Information:

Title

Iron isotopic composition of the blood

Description

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

Time Frame

1, 22, 43 and 64 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Funke Olumakaiye, PhD

Organizational Affiliation

Obafemi Awolowo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Obafemi Owalowo University

City

Ile Ife

Country

Nigeria

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31004134

Citation

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.

Results Reference

derived

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

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