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Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children

Primary Purpose

Micronutrient Deficiencies, Anemia, Fortification

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Placebo
Formative messgaes
Fortified product
Fortified product plus
Sponsored by
University of Veterinary and Animal Sciences, Lahore - Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Micronutrient Deficiencies

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 3-5 years of age
  • no medical complication
  • from middle-income group within the semi-urban population

Exclusion Criteria:

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

Sites / Locations

  • University of Veterinary and Animal Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control

Formative messages

Fortified product

Fortified product plus

Arm Description

this group, only placebo product will be given

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

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

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

Outcomes

Primary Outcome Measures

To access the improvement in child Iron deficiency anemia
change in serum Hemoglobin, serum ferritin and serum transferrin receptors
To access the improvement in children Vitamin A status
Change in Serum retinol binding protein
To access the improvement in children Zinc status
Change in serum zinc

Secondary Outcome Measures

Difference in the children anthropocentric status
Mean z-scores (weight-for-age, length-for-age z-scores, weight-for-length) based on the WHO child growth standards 2006
Effect on the household food security
Diet diversity score based on dietary intake and preferences by 24 hrs dietary recall and Household Food Security Scale
Enhancement in the early childhood development indicators
Gain change in the cognitive, motor and socio-emotional assessment through questionnaire filled by caretaker

Full Information

First Posted
January 25, 2018
Last Updated
February 22, 2018
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
Collaborators
Sindh Lady Health Worker Program for Family Planning and Primary Health Care, PCSIR Laboratories Complex Karachi Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT03450174
Brief Title
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
Official Title
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
July 28, 2018 (Anticipated)
Study Completion Date
August 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
Collaborators
Sindh Lady Health Worker Program for Family Planning and Primary Health Care, PCSIR Laboratories Complex Karachi Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
As per the National Nutrition Survey, 2011 anaemia (iron deficiency) affected the children severely as one in three children under the age of 5 anemic, whereas prevalence of vitamin A deficiency among children under 5 years is more than 50%, similarly Zinc deficiency children and vitamin D deficiency prevalence in children is more than 40%. The numerous indicators of nutrition deficiencies are related to inadequately nutritious and safe food, illiteracy, malpractices along with lack of nutritional knowledge and other social and behavioral issues. A healthy and supportive nutritional status, direct toward better intellect and earning of individual, which boost the social impact and macro level change. Childhood stunting and deficiencies in iron and iodine hamper cognitive development, school achievement and adult productivity by 2.5-19.8 percent subsequently adult anemia reduces work performance in manual labor in the agriculture area and overall resultant US$ 7.6 billion annually loss for Pakistan, which corresponds to nearly 3 percent of GDP all due to poor nutritional indicators, which are preventable. Therefore, in developing countries like Pakistan, robust need is required, to do evidence base and translational research which could be easily converted into action that improves nutritional status. Food fortification with micro-nutrients is effective, cost-efficient and medium-term approach to improve micro-nutrient status of vulnerable groups and is sustainable once established to prevent these at cheaper cost. There is need to investigate the positive effects of multiple micronutrient administration on child development along with there is dire need for more research to investigate it comprehensively at community level. Fortified food products such as (milk, wheat, rice, oil, and other) are already in existing strategies worldwide to prevent micro-nutrient deficiencies in society which is well established and currently there are several extensive activities are implemented to prevent these hidden hunger but required results are not achieved. On the other hand, other smart solutions are emerging to prevent these deficiencies at wider level in best possible means, among them fortified candy with multiple micronutrients is one vehicle. Confectionery products have the potential to carry the micronutrient for better delivery and doesn't significantly affect the flavour, taste and texture of the product. The objective of the study is to determine the nutritional status, factor causing micronutrient deficiencies in pre-school children in semi-urban area of Karachi and how fortified product and enhance nutritional knowledge can bring change in nutritional indicators and understanding of nutrition in community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Micronutrient Deficiencies, Anemia, Fortification, Undernutrition, Early Childhood Development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
this group, only placebo product will be given
Arm Title
Formative messages
Arm Type
Experimental
Arm Description
this group will be received only daily formative messages on diet diversity, healthy and best nutrition practices
Arm Title
Fortified product
Arm Type
Experimental
Arm Description
this group will be received only fortified product on alternate day up to 6 months
Arm Title
Fortified product plus
Arm Type
Experimental
Arm Description
this group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
In control group, participants will receive only a placebo product
Intervention Type
Behavioral
Intervention Name(s)
Formative messgaes
Intervention Description
In this group, participants will only receive daily formative messages
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortified product
Intervention Description
In this group, participants will receive fortified product on alternate day up till 8 months
Intervention Type
Combination Product
Intervention Name(s)
Fortified product plus
Intervention Description
In this group participants will receive fortified product on alternate day and formative messages up till 8 months
Primary Outcome Measure Information:
Title
To access the improvement in child Iron deficiency anemia
Description
change in serum Hemoglobin, serum ferritin and serum transferrin receptors
Time Frame
Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Title
To access the improvement in children Vitamin A status
Description
Change in Serum retinol binding protein
Time Frame
Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Title
To access the improvement in children Zinc status
Description
Change in serum zinc
Time Frame
Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Secondary Outcome Measure Information:
Title
Difference in the children anthropocentric status
Description
Mean z-scores (weight-for-age, length-for-age z-scores, weight-for-length) based on the WHO child growth standards 2006
Time Frame
Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Title
Effect on the household food security
Description
Diet diversity score based on dietary intake and preferences by 24 hrs dietary recall and Household Food Security Scale
Time Frame
Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Title
Enhancement in the early childhood development indicators
Description
Gain change in the cognitive, motor and socio-emotional assessment through questionnaire filled by caretaker
Time Frame
Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 3-5 years of age no medical complication from middle-income group within the semi-urban population Exclusion Criteria: illness/ infections (TB, Malarial drug) non-attendant severe anemia/micro nutrient deficiency thyroid disease medication/supplementation not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fakhar Gulzar
Organizational Affiliation
University of Veterinary and Animal Sciences, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Veterinary and Animal Sciences
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children

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