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Effect of Nutrisus in preventing anemia in children under six years old

Acceptability and effectiveness of Nutrisus in the prevention of anemia and iron deficiency in children under six years old

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-46n583h
Enrollment
Unknown
Registered
2022-09-21
Start date
2021-08-01
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

Iron deficiency anemia

Interventions

Iron - 10mg
Zinc - 4.1mg
Copper - 0.56mg
Selenium - 17µg
Folic Acid - 150µg
This is a single-blind randomized controlled trial. The sample will consist of 100 children aged 1 to 6 years equally allocated into 2 groups (intervention and control) with 50 children in each one. T
Vitamin D - 5µg
Vitamin E TE - 5mg
Vitamin C - 30mg
Vitamin B1 - 0.5mg
Vitamin B2 - 0.5mg
Vitamin B6 - 0.5mg
Vitamin B12 - 0.9µg
Niacin - 6mg
and Iodine - 90µg. Children in both groups, at baseline and at the end of 60 days, will undergo an anthropometric assessment to obtain weight and height. In addition, samples of up to 5 mL of fasting
G07.203.300.456

Sponsors

Ana Paula Grotti Clemente
Lead Sponsor
Universidade Federal de Alagoas
Collaborator

Eligibility

Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children aged 1 to 6 years enrolled at Centro de Recuperação e Educação Nutricional who are not using iron supplementation at the time of recruitment

Exclusion criteria

Exclusion criteria: Children diagnosed with neurological or hematological diseases of genetic and autoimmune origin (sickle cell, hemolytic, sideroblastic and aplastic anemia, Fanconi anemia and thalassemia), who use iron supplementation at the time of recruitment, or with a diagnosis of anemia due to other nutritional causes: megaloblastic and pernicious anemias

Design outcomes

Primary

MeasureTime frame
Nutrisus is expected to be effective for the prevention and treatment of anemia evaluated through blood collection to measure the biochemical concentrations of hemoglobin and ferritin. It is expected to find a 38% lower prevalence of anemia in children who received powdered micronutrient sachets when compared to the control group

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactAna Paula Clemente

Universidade Federal de Alagoas

anagrotticlemente@gmail.com+55-82-32141041

Outcome results

None listed

Source: REBEC (via WHO ICTRP)