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Completed

NCT Number: NCT02815449

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obafemi Owalowo University

Ile-Ife, Nigeria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 Medium stabilizer level

Other

Meals prepared with iron fortified cube with Medium stabilizer level

Meals prepared with iron fortified cube with High stabilizer level

Other

Meals prepared with iron fortified cube with High stabilizer level

Primary outcomes

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

    Time frame: 16 days

    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 outcomes

  1. Iron isotopic composition of the blood

    Time frame: 1, 22, 43 and 64 days

    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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Obafemi Awolowo University

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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