NCT05412238

Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months

Formulation and Production of Macro- and Micronutrient Sachets for Home Fortification and Evaluation of Their Efficacy on Pregnant Mothers and Children Aged 6-60 Months in Sistan Baloochestan

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 6 Months – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of the present study is formulation and production of sachets containing macronutrients and micronutrients to enrich food at home and evaluate its effectiveness on pregnant mothers and children aged 6 to 60 months living in Sistan and Baluchestan province

Detailed description

This study is conducted in three steps. At first, fortification sachets are formulated and produced in accordance with international recommendations for micronutrients (vitamins A, D, zinc, and iron) and macronutrients for use in normal home conditions. In the second step, efficacy of fortified sachets are evaluate in three subgroups including pregnant mothers, 6-24 months and 2-5 years old children. Nutritional, anthropometrical and biochemical indices are evaluated at the beginning and after 6-9 months intervention. At the third step, costs and cost-effectiveness of the intervention in each of the studied groups in comparison with the usual program for that age group in the health care system of the country is determined.

Conditions

• Pregnancy
• Childhood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	micro-and macro-nutrients fortified sachets	Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-01-01
• Completion: 2023-02-01
• First posted: 2022-06-09
• Last updated: 2022-06-09

Locations

1 site across 1 country: Iran