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

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: G07.203.300.456 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. The intervention group will be composed of non‐anemic children who will receive standard lunch offered at Center for Nutritional Recovery and Education (CREN‐AL) containing the NutriSUS sachet and the control group will be composed of non‐anemic children who will receive the same standard lunch offered at the center of recovery, but without the addition of the NutriSUS sachet. In the intervention group, during a period of 60 days, 1 sachet of micronutrients in powder will be added to one of the children's meals held at the CREN‐AL. The sachet is composed of 15 micronutrients: Vitamin A RE ‐ 400µg; 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; Folic Acid ‐ 150µg; Iron ‐ 10mg; Zinc ‐ 4.1mg; Copper ‐ 0.56mg; Selenium ‐ 17µg; 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 venous blood will be collected for evaluation of serum ferritin concentrations and complete blood count. CONDITION: C15.378.071 Iron deficiency anemia PRIMARY OUTCOME: 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 OUTCOME: Secondary outcomes are not expected. 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
Epistemonikos ID: 255d083cdbb162c66f6676180cb6e41fe202b8b9
First added on: Aug 26, 2024