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

June 6, 2022 updated by: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tirang R. Neyestani, PhD
  • Phone Number: 982122376471
  • Email: neytr@yahoo.com

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight gain during pregnancy
Time Frame: 6-9 months
Weight difference at the beginning and end of pregnancy
6-9 months
Birth weight
Time Frame: 6-9 months
Measured weight (kg) at the first day of life
6-9 months
Weight for age
Time Frame: 6-9 months
Measured weight (kg) in a specific age (year)
6-9 months
Weight for height
Time Frame: 6-9 months
The ratio of weight (kg) to height(m)
6-9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
25-hydroxyvitamin D (nmol/L)
Time Frame: 6-9 months
Fasting serum 25-hydroxyvitamin D level
6-9 months
Hemoglobin (g/dL)
Time Frame: 6-9 months
Blood hemoglobin level
6-9 months
Serum ferritin (ng/mL)
Time Frame: 6-9 months
Fasting serum ferritin level
6-9 months
Serum zinc (microg/dL)
Time Frame: 6-9 month
Fasting serum zinc level
6-9 month
Serum retinol (micromol/L)
Time Frame: 6-9 months
Fasting serum retinol level
6-9 months
Serum folate (ng/mL)
Time Frame: 6-9 months
Fasting serum folate level
6-9 months
Serum B12 (pg/mL)
Time Frame: 6-9 months
Fasting serum B12 level
6-9 months
Apgar score
Time Frame: 6-9 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Nutrition and Food Technology Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tirang R. Neyestani, PhD, NationalNFTI, SBMU, Tehran, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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