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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Micronutrient Deficiencies, Anemia, Fortification, Undernutrition, Early Childhood Development

Intervention / Treatment
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* Dietary Supplement: Placebo
* Behavioral: Formative messgaes
* Dietary Supplement: Fortified product
* Combination Product: Fortified product plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>this group, only placebo product will be given | Dietary Supplement: Placebo<br>* In control group, participants will receive only a placebo product<br>|
| Experimental: Formative messages<br>this group will be received only daily formative messages on diet diversity, healthy and best nutrition practices | Behavioral: Formative messgaes<br>* In this group, participants will only receive daily formative messages<br>|
| Experimental: Fortified product<br>this group will be received only fortified product on alternate day up to 6 months | Dietary Supplement: Fortified product<br>* In this group, participants will receive fortified product on alternate day up till 8 months<br>|
| Experimental: Fortified product plus<br>this group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices | Combination Product: Fortified product plus<br>* In this group participants will receive fortified product on alternate day and formative messages up till 8 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |