- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03450174
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- University of Veterinary and Animal Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
this group, only placebo product will be given
|
In control group, participants will receive only a placebo product
|
Experimental: Formative messages
this group will be received only daily formative messages on diet diversity, healthy and best nutrition practices
|
In this group, participants will only receive daily formative messages
|
Experimental: Fortified product
this group will be received only fortified product on alternate day up to 6 months
|
In this group, participants will receive fortified product on alternate day up till 8 months
|
Experimental: Fortified product plus
this group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices
|
In this group participants will receive fortified product on alternate day and formative messages up till 8 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To access the improvement in child Iron deficiency anemia
Time Frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
|
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
Time Frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
|
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
Time Frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
|
Change in serum zinc
|
Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the children anthropocentric status
Time Frame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
|
Mean z-scores (weight-for-age, length-for-age z-scores, weight-for-length) based on the WHO child growth standards 2006
|
Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
|
Effect on the household food security
Time Frame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
|
Diet diversity score based on dietary intake and preferences by 24 hrs dietary recall and Household Food Security Scale
|
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
Time Frame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
|
Gain change in the cognitive, motor and socio-emotional assessment through questionnaire filled by caretaker
|
Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fakhar Gulzar, University of Veterinary and Animal Sciences, lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversityVAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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