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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05412238
Other study ID # 27
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date February 2023

Study information

Verified date June 2022
Source National Nutrition and Food Technology Institute
Contact Tirang R. Neyestani, PhD
Phone 982122376471
Email neytr@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
micro-and macro-nutrients fortified sachets
Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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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