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Effect of fortification with powder nutrients in prevention and treatment of nutrient deficiency

Effectiveness of fortification with powder micronutrients in prevention and treatment of micronutrient deficiency: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4hm7mz
Enrollment
Unknown
Registered
2018-07-23
Start date
2018-05-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deficiency Diseases

Interventions

Intervention group: anemic children will receive the NutriSUS strategy sachet supplemented with 3.2 mg/kg/ day of ferrous sulfate in the day care center and non-anemic children will only receive the s
Drug
Dietary supplement
D27.505.696.377.605

Sponsors

Faculdade de Nutrição da Universidade Federal de Goiás
Lead Sponsor
Faculdade de Nutrição da Universidade Federal de Goiás
Collaborator

Eligibility

Age
6 Months to 48 Months

Inclusion criteria

Inclusion criteria: Children aged six to 48 months; anemic and non-anemic.

Exclusion criteria

Exclusion criteria: Children in treatment of anemia; malaria; HIV, hemoglobinopathies or hemochromatosis; low weight at birth; preterm birth (less than 37 weeks); twin; allergies reported to any components of the fortification sachet and/or to ferrous sulfate/folic acid.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the difference in mean serum hemoglobin levels, verified by electronic counting, between children receiving Nutrisus or supplementation with iron and folic acid, measured before and after the intervention.

Secondary

MeasureTime frame
Any change in serum vitamin A, verified by High Performance Liquid Chromatography (HPLC), measured before and after the intervention.;Any change in serum vitamin E, verified by High Performance Liquid Chromatography (HPLC), measured before and after the intervention.;Any change in serum vitamin D, verified by amplified chemiluminescence, measured before and after the intervention.;Any change in serum folic acid level, verified by commercial fluoroimmunoassays, measured before and after the intervention.;Presence or absence of rs855791 polymorphism in the TMPRSS6 gene. Genotyping will be performed by real-time polymerase chain reaction (qPCR) using the inventoried assay (TaqMan® SNP Genotyping Assays, Waltham, Massachusetts, USA) for SNPs rs855791 located in the TMPRSS6 gene, which encodes a transmembrane serine protease 6. StepOne equipment will be used (Thermo Fisher Scientific, Massachusetts, USA).

Countries

Brazil

Contacts

Public ContactMaria Claret Hadler

Universidade Federal de Goiás

clarethadler@uol.com.br3209-6270

Outcome results

None listed

Source: REBEC (via WHO ICTRP)