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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pregnancy, Childhood

Intervention / Treatment
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* Dietary Supplement: micro-and macro-nutrients fortified sachets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women being in the first trimester of pregnancy free of chronic diseases before pregnancy no intention to change residence until delivery 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 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: Pregnant women premature termination of pregnancy change of residence before delivery Children 6 to 23 months -change of residence before delivery Children 2 to 5 years (60-24 months) -change of residence before delivery

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women receiving fortification sachets<br>pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months | Dietary Supplement: micro-and macro-nutrients fortified sachets<br>* Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months<br>|
| Experimental: 6-24 months old children receiving fortification sachets<br>6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months | Dietary Supplement: micro-and macro-nutrients fortified sachets<br>* Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months<br>|
| Experimental: 2-5 years old children receiving fortification sachets<br>2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months | Dietary Supplement: micro-and macro-nutrients fortified sachets<br>* Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain during pregnancy | Weight difference at the beginning and end of pregnancy | 6-9 months | 
| Birth weight | Measured weight (kg) at the first day of life | 6-9 months | 
| Weight for age | Measured weight (kg) in a specific age (year) | 6-9 months | 
| Weight for height | The ratio of weight (kg) to height(m) | 6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hydroxyvitamin D (nmol/L) | Fasting serum 25-hydroxyvitamin D level | 6-9 months | 
| Hemoglobin (g/dL) | Blood hemoglobin level | 6-9 months | 
| Serum ferritin (ng/mL) | Fasting serum ferritin level | 6-9 months | 
| Serum zinc (microg/dL) | Fasting serum zinc level | 6-9 month | 
| Serum retinol (micromol/L) | Fasting serum retinol level | 6-9 months | 
| Serum folate (ng/mL) | Fasting serum folate level | 6-9 months | 
| Serum B12 (pg/mL) | Fasting serum B12 level | 6-9 months | 
| Apgar score | The Apgar score is a quick evaluation of one minute and five minutes after birth which tests the birthing process and readiness of newborn to meet the world without additional medical assistance | 6-9 months |