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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Childhood
• Intervention / Treatment: Dietary supplement: micro-and macro-nutrients fortified sachets

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tirang R. Neyestani, PhD; Phone Number: 982122376471; Email: neytr@yahoo.com
• Study Contact Backup: Name: Bahareh Nikooyeh, PhD; Phone Number: 982122376471; Email: nikooyeh11024@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pregnant women receiving fortification sachets; pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months	Dietary supplement: micro-and macro-nutrients fortified sachets; Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months
EXPERIMENTAL: 6-24 months old children receiving fortification sachets; 6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months	Dietary supplement: micro-and macro-nutrients fortified sachets; Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months
EXPERIMENTAL: 2-5 years old children receiving fortification sachets; 2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months	Dietary supplement: micro-and macro-nutrients fortified sachets; Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute
• Investigators: Study Chair: Tirang R. Neyestani, PhD, NationalNFTI, SBMU, Tehran, Iran

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (ACTUAL): June 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No