Clinical trial NCT05412238: Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Childhood
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight gain during pregnancy
timeFrame: 6-9 months
measure: Birth weight
timeFrame: 6-9 months
measure: Weight for age
timeFrame: 6-9 months
measure: Weight for height
timeFrame: 6-9 months
Secondary outcomes:
measure: 25-hydroxyvitamin D (nmol/L)
timeFrame: 6-9 months
measure: Hemoglobin (g/dL)
timeFrame: 6-9 months
measure: Serum ferritin (ng/mL)
timeFrame: 6-9 months
measure: Serum zinc (microg/dL)
timeFrame: 6-9 month
measure: Serum retinol (micromol/L)
timeFrame: 6-9 months
measure: Serum folate (ng/mL)
timeFrame: 6-9 months
measure: Serum B12 (pg/mL)
timeFrame: 6-9 months
measure: Apgar score
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: 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
Study officials:
affiliation: NationalNFTI, SBMU, Tehran, Iran
name: Tirang R. Neyestani, PhD
role: STUDY_CHAIR
References: