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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05412238
• Other study ID #: 27
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Childhood
• Pregnancy

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