NCT05412238

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

June 6, 2022

Last Update Submit

June 6, 2022

Conditions

PregnancyChildhood

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • 25-hydroxyvitamin D (nmol/L)

    6-9 months

  • Hemoglobin (g/dL)

    6-9 months

  • Serum ferritin (ng/mL)

    6-9 months

  • Serum zinc (microg/dL)

    6-9 month

  • Serum retinol (micromol/L)

    6-9 months

  • +3 more secondary outcomes

Study Arms (3)

Pregnant women receiving fortification sachets

EXPERIMENTAL

pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months

Dietary Supplement: micro-and macro-nutrients fortified sachets

6-24 months old children receiving fortification sachets

EXPERIMENTAL

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

2-5 years old children receiving fortification sachets

EXPERIMENTAL

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

Interventions

micro-and macro-nutrients fortified sachetsDIETARY_SUPPLEMENT

Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months

2-5 years old children receiving fortification sachets6-24 months old children receiving fortification sachetsPregnant women receiving fortification sachets

Eligibility Criteria

Age6 Months - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women
  • being in the first trimester of pregnancy
  • free of chronic diseases before pregnancy
  • no intention to change residence until delivery
  • 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
  • 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

You may not qualify if:

  • Pregnant women
  • premature termination of pregnancy
  • change of residence before delivery
  • Children 6 to 23 months
  • change of residence before delivery
  • Children 2 to 5 years (60-24 months) -change of residence before delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Iran

Location

Study Officials

  • Tirang R. Neyestani, PhD

    NationalNFTI, SBMU, Tehran, Iran

    STUDY CHAIR

Central Study Contacts

Tirang R. Neyestani, PhD

CONTACT

982122376471neytr@yahoo.com

Bahareh Nikooyeh, PhD

CONTACT

982122376471nikooyeh11024@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations

IR(1)