NCT02815449

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

Completed NA Last updated 1 August 2017

What this trial tests

NA trial testing Meals prepared with iron fortified cube with Low stabilizer level in Iron Deficiency Anemia in 24 participants. Completed in 24 July 2017.

Timeline

8 May 2017

Primary endpoint
24 July 2017

24 July 2017

Quick facts

Lead sponsor	Unilever R&D
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	24
Start date	8 May 2017
Primary completion	24 July 2017
Estimated completion	24 July 2017
Sites	1 location across Nigeria

Drugs / interventions tested

• 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

Conditions studied

• Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →

Sponsor

Unilever R&D — full company profile →

Who can join

Adults 18 to 40, female only, with Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Eilander A, Funke OM, Moretti D, Zimmermann MB, et al · · 2019 · cited 3× · PMID 31004134 · DOI 10.1093/jn/nxz003