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

National Nutrition and Food Technology Institute

Status: Not yet enrolling

Conditions: Childhood; Pregnancy

Treatments: Dietary Supplement: micro-and macro-nutrients fortified sachets

Study type: Interventional

Funder types: Other

Identifiers

NCT05412238

27

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 months to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pregnant women

   • being in the first trimester of pregnancy
   • free of chronic diseases before pregnancy
   • no intention to change residence until delivery

2. Children 6 to 23 months

   • age 6 to 7 months
   • no intention to change residence or migrate in the next 12 months
   • free of acute or chronic illness

3. Children 2 to 5 years (60-24 months)

   • age 24 to 48 months
   • no intention to change residence or migrate in the next 6-12 months
   • free of acute or chronic diseases

Exclusion criteria

1. Pregnant women

   • premature termination of pregnancy
   • change of residence before delivery

2. Children 6 to 23 months

   -change of residence before delivery

3. Children 2 to 5 years (60-24 months) -change of residence before delivery

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Pregnant women receiving fortification sachets

Experimental group

Description:

pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months

Treatment:

Dietary Supplement: micro-and macro-nutrients fortified sachets

6-24 months old children receiving fortification sachets

Experimental group

Description:

6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months

Treatment:

Dietary Supplement: micro-and macro-nutrients fortified sachets

2-5 years old children receiving fortification sachets

Experimental group

Description:

2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months

Treatment:

Dietary Supplement: micro-and macro-nutrients fortified sachets