Clinical trial NCT02815449: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: Iron fortification
Bioavailability
Nigeria
Women
Bouillon cubes
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Obafemi Awolowo University
First posted: 2016-06-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Iron isotopic composition of the blood at the end of each intervention period
timeFrame: 16 days
Secondary outcomes:
measure: Iron isotopic composition of the blood
timeFrame: 1, 22, 43 and 64 days
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Obafemi Owalowo University
Study officials:
affiliation: Obafemi Awolowo University
name: Funke Olumakaiye, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.