Clinical trial NCT03450174: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Micronutrient Deficiencies
Anemia
Fortification
Undernutrition
Early Childhood Development
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
Collaborators: name: Sindh Lady Health Worker Program for Family Planning and Primary Health Care
name: PCSIR Laboratories Complex Karachi Pakistan
First posted: 2018-03-01
Enrollment: 480
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: To access the improvement in child Iron deficiency anemia
timeFrame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
measure: To access the improvement in children Vitamin A status
timeFrame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
measure: To access the improvement in children Zinc status
timeFrame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Secondary outcomes:
measure: Difference in the children anthropocentric status
timeFrame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
measure: Effect on the household food security
timeFrame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
measure: Enhancement in the early childhood development indicators
timeFrame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Veterinary and Animal Sciences
state: Punjab
Study officials:
affiliation: University of Veterinary and Animal Sciences, Lahore
name: Fakhar Gulzar
role: PRINCIPAL_INVESTIGATOR
References: