Impact of Trout Fish, Cow Milk With Egg, Vitamin D Supplementation, and Dietary Education on Vitamin D Status, Undernutrition, and Neurocognitive Outcomes Among School Children in Pakistan: An Open-label Individually Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorAga Khan University

About this trial

Vitamin D deficiency and undernutrition are major public health concerns globally, particularly among children in low-resource and high-altitude settings. In Pakistan, the recent national nutrition survey has reported alarmingly high prevalence rates of vitamin D deficiency, especially in Ghizer District of Gilgit-Baltistan, where 85% of children under five years of age are vitamin D deficient, placing them at heightened risk for rickets, impaired growth, weakened immune function, cognitive impairments, and long-term socio-economic consequences. This survey did not provide any information on the vitamin D deficiency status of school-going children in Pakistan. However, a study conducted in Karachi reported that 65% of children aged 6-12 years were deficient in vitamin D. Despite abundant natural resources, such as trout fish and locally available cow's milk and eggs, these nutrient-rich foods are underutilized due to limited awareness among local communities about the health benefits for children.

This issue is particularly urgent for the Aga Khan University (AKU) and the Aga Khan Education Service Pakistan (AKESP) 's schools in the region, where children's health is integral to academic success and long-term community development. Addressing micronutrient deficiencies aligns closely with AKU's and the Aga Khan Development Network's (AKDN) strategic priorities of improving early childhood development, promoting health equity, strengthening food security, and fostering local capacity through evidence-based interventions.

Therefore, this proposal aims to assess whether targeted local food and supplementation, including trout fish, whole cow milk with egg, and vitamin D supplements, can significantly reduce vitamin D deficiency and improve nutritional and cognitive outcomes among school children in AKESP schools.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 6-12 years

Enrolled in one of the selected AKESP schools

Parent/legal guardian provides written informed consent

Child provides written assent

Disqualifiers

Currently enrolled in another research study or regular consumption of nutritional supplements, including vitamin D

Known allergy or intolerance to fish, milk, or eggs

Diagnosed chronic medical conditions affecting growth or vitamin D metabolism (e.g., renal disease, liver disease, malabsorption disorders)

Severe acute illness at the time of enrolment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D supplement 4000 IU weekly

    Dietary supplement

    Vitamin D supplement 4000 IU weekly dose for 16 weeks, along with education on dietary diversity

  • 200 grams of cooked trout fish

    Other intervention

    200 grams of cooked trout fish (100 gram per serving, twice weekly) for 16 weeks, along with education on dietary diversity

  • 250 milliliters of whole cow milk + whole egg

    Other intervention

    250 milliliters of whole cow milk + whole egg 3 days a week during school hours for 16 weeks, along with education on dietary diversity

Treatment groups

304 Participants
are divided into 4 treatment groups
Group A: 200 grams of cooked trout fishExperimental treatment 1 intervention
Group B: 250 milliliters of whole cow milk + whole eggExperimental treatment 1 intervention
Group C: Vitamin D supplement 4000 IU weeklyExperimental treatment 1 intervention
Group D: Control Group, no additional mealNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Serum 25(OH)D concentrations

Time frame
16 weeks

Secondary outcomes

1

Child weight measurement in kilograms

Weight in kilograms at baseline and endline

Time frame
16 weeks
2

Child dietary diversity

Dietary diversity will also be assessed using a 24-hour food recall on a monthly basis

Time frame
16 weeks
3

Neurocognitive development

Neurocognitive development will be assessed by using Digit span test and Word List Recall.

Time frame
Baseline and after 6 months of intervention
4

Morbidity history

Time frame
16 weeks

Other outcomes

Sponsors and contacts

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