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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women receiving fortification sachets | Experimental | pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months |
|
| 6-24 months old children receiving fortification sachets | Experimental | 6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months |
|
| 2-5 years old children receiving fortification sachets | Experimental | 2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro-and macro-nutrients fortified sachets | Dietary Supplement | Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Pregnant women
Children 6 to 23 months
Children 2 to 5 years (60-24 months)
Exclusion Criteria:
Pregnant women
Children 6 to 23 months
-change of residence before delivery
Children 2 to 5 years (60-24 months) -change of residence before delivery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tirang R. Neyestani, PhD | Contact | 982122376471 | neytr@yahoo.com | |
| Bahareh Nikooyeh, PhD | Contact | 982122376471 | nikooyeh11024@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, PhD | NationalNFTI, SBMU, Tehran, Iran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran | Tehran | Iran |
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| 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 |