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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03450174
• Date of registration: 25/01/2018
• Prospective Registration: No
• Primary sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Public title: Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
• Scientific title: Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial
• Date of first enrolment: October 2, 2017
• Target sample size: 480
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03450174
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Double (Participant, Care Provider).
• Phase: N/A

Countries of recruitment

Pakistan

Contacts

• Name: Fakhar Gulzar
• Affiliation: University of Veterinary and Animal Sciences, Lahore

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Undernutrition

Micronutrient Deficiencies

Early Childhood Development

Fortification

Anemia

Intervention(s)

Behavioral: Formative messgaes

Dietary Supplement: Placebo

Combination Product: Fortified product plus

Dietary Supplement: Fortified product

Primary Outcome(s)

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)]

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)]

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)]

Secondary Outcome(s)

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)]

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)]

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)]

Secondary ID(s)

UniversityVAS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PCSIR Laboratories Complex Karachi Pakistan

Sindh Lady Health Worker Program for Family Planning and Primary Health Care