Baby Iron Bioavailability Study

Nestlé

Status: Completed

Conditions: Iron Bioavailability

Treatments: Other: Labeled iron salt Fe54; Other: Labeled iron salt Fe57; Other: Labeled iron salt Fe58

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03754543

18.05.INF

Details and patient eligibility

About

The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.

Full description

In 30 infants aged 6 to 14 months old, the investigator will administer in random order over 2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals) or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator will collect one blood sample at baseline and another sample at the end of each phase, thus 3 samples total. In these samples, fractional iron absorption and markers of iron and inflammation status will be measured . In addition, infant and child acceptability of one of the infant cereals will be assessed by using a questionnaire.

Enrollment: 30 patients

Sex: All

Ages: 6 to 14 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Infant age 6 - 14 months
2. Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
3. Capillary haemoglobin concentration > 70g/L
4. Z-scores for weight-for-age and weight-for-length > -2
5. Infant's parent(s) / legally acceptable representative is of legal age of consent, has anticipated residence in the area for the duration of the study, and is willing and able to fulfil the requirements of the study protocol
6. Infant is expected to consume the entire 25 g portion during infant cereal feeding based on the Investigator's judgement established via observations of feeding during the adaptation phase
7. Infant received a complete dose of intermittent preventive treatment with dihydroartemisinin piperaquine (IPTi-DP) as well a single dose of antihelminth treatment with Albendazole

Exclusion criteria

1. Parents not willing / not able to comply with the requirements of study protocol
2. Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
3. Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
4. Infants participating in any other clinical trial prior to enrollment
5. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 5 patient groups, including a placebo group

Testmeal A

Active Comparator group

Description:

A new, whole-grain infant cereal fortified with ferrous fumarate

Treatment:

Other: Labeled iron salt Fe54

Testmeal B

Active Comparator group

Description:

An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate

Treatment:

Other: Labeled iron salt Fe57

Testmeal C

Placebo Comparator group

Description:

An existing, refined grain infant cereal fortified with ferrous fumarate

Treatment:

Other: Labeled iron salt Fe54

Testmeal D

Active Comparator group

Description:

An existing, whole-grain infant cereal fortified with ferrous fumarate

Treatment:

Other: Labeled iron salt Fe57

Testmeal E

Active Comparator group

Description:

An existing, whole-grain infant cereal fortified with ferrous bisglycinate

Treatment:

Other: Labeled iron salt Fe58