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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Sindh Lady Health Worker Program for Family Planning and Primary Health Care
PCSIR Laboratories Complex Karachi Pakistan
Information provided by (Responsible Party):
Fakhar Gulzar, University of Veterinary and Animal Sciences, Lahore - Pakistan

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Pakistan
University of Veterinary and Animal Sciences
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
University of Veterinary and Animal Sciences, Lahore - Pakistan
Sindh Lady Health Worker Program for Family Planning and Primary Health Care
PCSIR Laboratories Complex Karachi Pakistan
Investigators
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Principal Investigator: Fakhar Gulzar University of Veterinary and Animal Sciences, Lahore
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Responsible Party: Fakhar Gulzar, PhD Scholar, University of Veterinary and Animal Sciences, Lahore - Pakistan
ClinicalTrials.gov Identifier: NCT03450174    
Other Study ID Numbers: UniversityVAS
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders