NCT03450174

Brief Summary

Multiple micro-nutrient deficiencies in Pakistan is wide spread, there is dire need to address these by using smart solutions, among them multiple fortified product (fudge) is an alternate possible way to address this issue. Fortified products have the potential to reduce micronutrient deficiencies in children, therefore in current study children from 3-5 years will receive fortified product along with enhance nutrition promotional information to bring change in their dietary practices and nutritional indices.

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
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

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

Study Start

First participant enrolled

October 2, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

January 25, 2018

Last Update Submit

February 22, 2018

Conditions

Micronutrient DeficienciesAnemiaFortificationUndernutritionEarly Childhood Development

Outcome Measures

Primary Outcomes (3)

  • To access the improvement in child Iron deficiency anemia

    change in serum Hemoglobin, serum ferritin and serum transferrin receptors

    Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)

  • To access the improvement in children Vitamin A status

    Change in Serum retinol binding protein

    Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)

  • To access the improvement in children Zinc status

    Change in serum zinc

    Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)

Secondary Outcomes (3)

  • Difference in the children anthropocentric status

    Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)

  • Effect on the household food security

    Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)

  • Enhancement in the early childhood development indicators

    Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)

Study Arms (4)

Control

PLACEBO COMPARATOR

this group, only placebo product will be given

Dietary Supplement: Placebo

Formative messages

EXPERIMENTAL

this group will be received only daily formative messages on diet diversity, healthy and best nutrition practices

Behavioral: Formative messgaes

Fortified product

EXPERIMENTAL

this group will be received only fortified product on alternate day up to 6 months

Dietary Supplement: Fortified product

Fortified product plus

EXPERIMENTAL

this group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices

Combination Product: Fortified product plus

Interventions

PlaceboDIETARY_SUPPLEMENT

In control group, participants will receive only a placebo product

Control
Formative messgaesBEHAVIORAL

In this group, participants will only receive daily formative messages

Formative messages
Fortified productDIETARY_SUPPLEMENT

In this group, participants will receive fortified product on alternate day up till 8 months

Fortified product
Fortified product plusCOMBINATION_PRODUCT

In this group participants will receive fortified product on alternate day and formative messages up till 8 months

Fortified product plus

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • no medical complication
  • from middle-income group within the semi-urban population

You may not qualify if:

  • illness/ infections (TB, Malarial drug)
  • non-attendant
  • severe anemia/micro nutrient deficiency
  • thyroid disease
  • medication/supplementation
  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Veterinary and Animal Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

AnemiaMalnutrition

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Fakhar Gulzar

    University of Veterinary and Animal Sciences, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Scholar

Study Record Dates

First Submitted

January 25, 2018

First Posted

March 1, 2018

Study Start

October 2, 2017

Primary Completion

July 28, 2018

Study Completion

August 30, 2018

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Locations

PA(1)