Childhood, Pregnancy
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTmicro-and macro-nutrients fortified sachets
Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain during pregnancy | 6-9 months | Weight difference at the beginning and end of pregnancy |
| Birth weight | 6-9 months | Measured weight (kg) at the first day of life |
| Weight for age | 6-9 months | Measured weight (kg) in a specific age (year) |
| Weight for height | 6-9 months | The ratio of weight (kg) to height(m) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum retinol (micromol/L) | 6-9 months | Fasting serum retinol level |
| Serum folate (ng/mL) | 6-9 months | Fasting serum folate level |
| 25-hydroxyvitamin D (nmol/L) | 6-9 months | Fasting serum 25-hydroxyvitamin D level |
| Apgar score | 6-9 months | 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 |
| Serum B12 (pg/mL) | 6-9 months | Fasting serum B12 level |
| Hemoglobin (g/dL) | 6-9 months | Blood hemoglobin level |
| Serum ferritin (ng/mL) | 6-9 months | Fasting serum ferritin level |
| Serum zinc (microg/dL) | 6-9 month | Fasting serum zinc level |
Countries
Iran
Contacts
Primary ContactTirang R. Neyestani, PhD
Backup ContactBahareh Nikooyeh, PhD
Outcome results
None listed