Pregnancy Clinical Trial
Official title:
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
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
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | February 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | 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 |
Lead Sponsor | Collaborator |
---|---|
National Nutrition and Food Technology Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight gain during pregnancy | Weight difference at the beginning and end of pregnancy | 6-9 months | |
Primary | Birth weight | Measured weight (kg) at the first day of life | 6-9 months | |
Primary | Weight for age | Measured weight (kg) in a specific age (year) | 6-9 months | |
Primary | Weight for height | The ratio of weight (kg) to height(m) | 6-9 months | |
Secondary | 25-hydroxyvitamin D (nmol/L) | Fasting serum 25-hydroxyvitamin D level | 6-9 months | |
Secondary | Hemoglobin (g/dL) | Blood hemoglobin level | 6-9 months | |
Secondary | Serum ferritin (ng/mL) | Fasting serum ferritin level | 6-9 months | |
Secondary | Serum zinc (microg/dL) | Fasting serum zinc level | 6-9 month | |
Secondary | Serum retinol (micromol/L) | Fasting serum retinol level | 6-9 months | |
Secondary | Serum folate (ng/mL) | Fasting serum folate level | 6-9 months | |
Secondary | Serum B12 (pg/mL) | Fasting serum B12 level | 6-9 months | |
Secondary | 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 |
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