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

NCT02815449 | Completed

• 1 other identifier: FDS-SAV-2103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Iron fortification; Bioavailability; Nigeria; Women; Bouillon cubes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Iron isotopic composition of the blood

  1, 22, 43 and 64 days

Study Arms (3)

Low stabilizer level

EXPERIMENTAL

Meals prepared with iron fortified cube with low stabilizer level

Other: Meals prepared with iron fortified cube with Low stabilizer level

Medium stabilizer level

EXPERIMENTAL

Meals prepared with iron fortified cube with medium stabilizer level

Other: Meals prepared with iron fortified cube with Medium stabilizer level

High stabilizer level

EXPERIMENTAL

Meals prepared with iron fortified cube with high stabilizer level

Other: Meals prepared with iron fortified cube with High stabilizer level

Interventions

Meals prepared with iron fortified cube with Low stabilizer level OTHER

Meals prepared with iron fortified cube with Low stabilizer level

Low stabilizer level

Meals prepared with iron fortified cube with Medium stabilizer level OTHER

Meals prepared with iron fortified cube with Medium stabilizer level

Medium stabilizer level

Meals prepared with iron fortified cube with High stabilizer level OTHER

Meals prepared with iron fortified cube with High stabilizer level

High stabilizer level

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unilever R&D: lead
• Obafemi Awolowo University: collaborator

Study Sites (1)

Obafemi Owalowo University

Ile-Ife, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 31004134 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Funke Olumakaiye, PhD

  Obafemi Awolowo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 28, 2016
• Study Start: May 8, 2017
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

NG (1)