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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Other: Meals prepared with iron fortified cube with Low stabilizer level; Other: Meals prepared with iron fortified cube with Medium stabilizer level; Other: Meals prepared with iron fortified cube with High stabilizer level

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ile Ife, Nigeria
    • Obafemi Owalowo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low stabilizer level; Meals prepared with iron fortified cube with low stabilizer level	Other: Meals prepared with iron fortified cube with Low stabilizer level; Meals prepared with iron fortified cube with Low stabilizer level
Experimental: Medium stabilizer level; Meals prepared with iron fortified cube with medium stabilizer level	Other: Meals prepared with iron fortified cube with Medium stabilizer level; Meals prepared with iron fortified cube with Medium stabilizer level
Experimental: High stabilizer level; Meals prepared with iron fortified cube with high stabilizer level	Other: Meals prepared with iron fortified cube with High stabilizer level; Meals prepared with iron fortified cube with High stabilizer level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Obafemi Awolowo University
• Investigators: Principal Investigator: Funke Olumakaiye, PhD, Obafemi Awolowo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): July 24, 2017
• Study Completion (Actual): July 24, 2017

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Women; Bioavailability; Iron fortification; Nigeria; Bouillon cubes
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: FDS-SAV-2103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No