Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
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|ClinicalTrials.gov Identifier: NCT03450174|
Recruitment Status : Unknown
Verified February 2018 by Fakhar Gulzar, University of Veterinary and Animal Sciences, Lahore - Pakistan.
Recruitment status was: Active, not recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Micronutrient Deficiencies Anemia Fortification Undernutrition Early Childhood Development||Dietary Supplement: Placebo Behavioral: Formative messgaes Dietary Supplement: Fortified product Combination Product: Fortified product plus||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial|
|Actual Study Start Date :||October 2, 2017|
|Estimated Primary Completion Date :||July 28, 2018|
|Estimated Study Completion Date :||August 30, 2018|
Placebo Comparator: Control
this group, only placebo product will be given
Dietary Supplement: Placebo
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
Behavioral: Formative messgaes
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
Dietary Supplement: Fortified product
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
Combination Product: Fortified product plus
In this group participants will receive fortified product on alternate day and formative messages up till 8 months
- 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
- 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
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450174
|University of Veterinary and Animal Sciences|
|Lahore, Punjab, Pakistan, 54000|
|Principal Investigator:||Fakhar Gulzar||University of Veterinary and Animal Sciences, Lahore|