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

Anemia Clinical Trial

Official title:

Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03450174
• Other study ID #: UniversityVAS
• Status: Active, not recruiting
• Phase: N/A
• First received: January 25, 2018
• Last updated: February 22, 2018
• Start date: October 2, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: February 2018
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: August 30, 2018
• Est. primary completion date: July 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Early Childhood Development
• Fortification
• Malnutrition
• Micronutrient Deficiencies
• Undernutrition

Intervention

Dietary Supplement:
• Placebo
In control group, participants will receive only a placebo product

Behavioral:
• Formative messgaes
In this group, participants will only receive daily formative messages

Dietary Supplement:
• Fortified product
In this group, participants will receive fortified product on alternate day up till 8 months

Combination Product:
• Fortified product plus
In this group participants will receive fortified product on alternate day and formative messages up till 8 months

Locations

Country	Name	City	State
Pakistan	University of Veterinary and Animal Sciences	Lahore	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan	PCSIR Laboratories Complex Karachi Pakistan, Sindh Lady Health Worker Program for Family Planning and Primary Health Care

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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	Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Secondary	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	Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Secondary	Enhancement in the early childhood development indicators	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)