Vitamin D, nutrition, and brain health in Pakistani schoolchildren

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, individually randomized trial evaluates the combined effect of weekly 4000 IU vitamin D, 200 g cooked trout, 250 ml whole milk plus one whole egg, and dietary education on vitamin D status, undernutrition, and neurocognitive outcomes over four months in healthy schoolchildren. Participants are 6-12 years old, enrolled in selected AKESP schools, and provide baseline and 4-month blood samples to measure vitamin D. The study uses a pragmatic design to reflect real-world dietary changes, with parent consent and child assent, and excludes those with conflicting medications, chronic illnesses, or allergies to fish, milk, or eggs. Primary outcomes include vitamin D status and growth measures, with exploratory neurocognitive assessments.

Why it matters

Who can join: the full rules

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:

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

Where it's running

• Aga Khan University
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Principal investigator: Gul Nawaz Khan, MPH — Aga Khan University
• Study coordinator: Gul Nawaz Khan, MPH
• Email: gul.nawaz@aku.edu
• Phone: +92 21 33109538

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.