CClinicalTrials.gg
RecruitingNCT07864662Updated Oct 8, 2026

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

An interventional study of Vitamin D supplement 4000 IU weekly and 200 grams of cooked trout fish in Vitamin D 25-Hydroxylase Deficiency, Undernutrition and Neurocognitive Development, sponsored by Aga Khan University. Recruiting at 1 site in Pakistan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Vitamin D 25-Hydroxylase Deficiency
  • Undernutrition
  • Neurocognitive Development

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Keywords

  • Vitamin D
  • Trout Fish
  • Cow Milk
  • Egg
  • Vitamin D Supplementation
  • Dietary Education
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 304 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Aga Khan University is the lead sponsor of 291 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Children will be included in the study if they meet all of the following criteria:

  • Aged 6-12 years
  • Enrolled in one of the selected AKESP schools
  • Parent/legal guardian provides written informed consent
  • Child provides written assent
  • Willing to participate in the full 4-month study period
  • Willing to provide a blood sample for a vitamin D test at baseline and after 4 months
  • Apparently healthy at the time of enrolment

Exclusion criteria

Exclusion Criteria:

Children will be excluded if they meet any of the following criteria:

  • 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
  • Physical or developmental conditions that prevent participation in study assessments
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
304 participants (estimated)

Study arms

  • Experimental
    200 grams of cooked trout fish

    Group 1: 200 grams of cooked trout fish (100 gram per serving, twice weekly) for 16 weeks, along with education on dietary diversity.

    Other: 200 grams of cooked trout fish

  • Experimental
    250 milliliters of whole cow milk + whole egg

    Group 2: 250 milliliters of whole cow milk + whole egg 3 days a week during school hours for 16 weeks, along with education on dietary diversity.

    Other: 250 milliliters of whole cow milk + whole egg

  • Experimental
    Vitamin D supplement 4000 IU weekly

    Group 3: Vitamin D supplement 2000 IU twice a week for 16 weeks, along with education on dietary diversity.

    Dietary Supplement: Vitamin D supplement 4000 IU weekly

  • No intervention
    Control Group, no additional meal

    Group 4: Control Group, no additional meal will be provided during the intervention phase. After the study is completed, these children will receive a vitamin D supplement of 2000 IU twice a week for 16 weeks, along with education on dietary diversity.

Interventions

  • Dietary supplementVitamin D supplement 4000 IU weekly

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

  • Other200 grams of cooked trout fish

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

  • Other250 milliliters of whole cow milk + whole egg

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

06

What researchers measure

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

  5. School attendance

    Time frame: 16 weeks

  6. Child height measurement in centimeters

    Height measurement in centimeters at baseline and endline

    Time frame: 16 weeks

  7. Child mid-upper arm circumference measurement in centimeters

    Mid-upper arm circumference measurement in centimeters at baseline and endline

    Time frame: 16 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07864662
Lead sponsor
Aga Khan University
Responsible party
Gul Nawaz Khan (Assistant Professor, Aga Khan University) — Principal investigator
First posted
Oct 8, 2026
Start date
Aug 10, 2026
Primary completion
Feb 28, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Gul Nawaz Khan, MPH
Contact
gul.nawaz@aku.edu
+92 21 33109538 ext. 69538
Gul Nawaz Khan, MPH
principal investigator · Aga Khan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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