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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03450174
Enrollment
480
Registered
2018-03-01
Start date
2017-10-02
Completion date
2018-08-30
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

In control group, participants will receive only a placebo product

BEHAVIORALFormative messgaes

In this group, participants will only receive daily formative messages

DIETARY_SUPPLEMENTFortified product

In this group, participants will receive fortified product on alternate day up till 8 months

COMBINATION_PRODUCTFortified product plus

In this group participants will receive fortified product on alternate day and formative messages up till 8 months

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To access the improvement in child Iron deficiency anemiaWill 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 statusWill 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 statusWill be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)Change in serum zinc

Secondary

MeasureTime frameDescription
Difference in the children anthropocentric statusBase-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 securityBase-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 indicatorsBase-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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026