Vitamin D 25-Hydroxylase DeficiencyNCT07864662
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
A study testing Vitamin D supplement 4000 IU weekly, 200 grams of cooked trout fish and 250 milliliters of whole cow milk + whole egg in people with Vitamin D 25-Hydroxylase Deficiency and Undernutrition, run by Aga Khan University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Vitamin D 25-Hydroxylase Deficiency, Undernutrition, Neurocognitive Development
- What is being tested?
- Vitamin D supplement 4000 IU weekly, 200 grams of cooked trout fish and 250 milliliters of whole cow milk + whole egg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Gul Nawaz Khan, 03008298976, gul.nawaz@aku.edu
Ahmad Khan, MA, +92 21 33109527 ext. 69527, ahmad.sherali@aku.edu
About this study
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.
- Being tested
- Vitamin D supplement 4000 IU weekly, 200 grams of cooked trout fish, 250 milliliters of whole cow milk + whole egg
- Keywords
- Vitamin D, Trout Fish, Cow Milk, Egg, Vitamin D Supplementation, Dietary Education
- Medical subject headings
- Vitamin D Hydroxylation-Deficient Rickets, Type 1B, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplement 4000 IU weeklyDietary supplement
Vitamin D supplement 4000 IU weekly dose for 16 weeks, along with education on dietary diversity
200 grams of cooked trout fishOther
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 eggOther
250 milliliters of whole cow milk + whole egg 3 days a week during school hours for 16 weeks, along with education on dietary diversity
| Study group | Role | What they receive |
|---|---|---|
| 200 grams of cooked trout fish | Experimental | Group 1: 200 grams of cooked trout fish (100 gram per serving, twice weekly) for 16 weeks, along with education on dietary diversity. Receives: Other: 200 grams of cooked trout fish |
| 250 milliliters of whole cow milk + whole egg | Experimental | 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. Receives: Other: 250 milliliters of whole cow milk + whole egg |
| Vitamin D supplement 4000 IU weekly | Experimental | Group 3: Vitamin D supplement 2000 IU twice a week for 16 weeks, along with education on dietary diversity. Receives: Dietary Supplement: Vitamin D supplement 4000 IU weekly |
| Control Group, no additional meal | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D concentrations
Measured: 16 weeks
Secondary outcomes (7)
Child weight measurement in kilograms
Weight in kilograms at baseline and endline
Measured: 16 weeks
Child dietary diversity
Dietary diversity will also be assessed using a 24-hour food recall on a monthly basis
Measured: 16 weeks
Neurocognitive development
Neurocognitive development will be assessed by using Digit span test and Word List Recall.
Measured: Baseline and after 6 months of intervention
Morbidity history
Measured: 16 weeks
School attendance
Measured: 16 weeks
Child height measurement in centimeters
Height measurement in centimeters at baseline and endline
Measured: 16 weeks
Child mid-upper arm circumference measurement in centimeters
Mid-upper arm circumference measurement in centimeters at baseline and endline
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Aug 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D 25-Hydroxylase DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Nawaz Khan, Aga Khan University
- Investigators
- Gul Nawaz Khan, MPH, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864662
- Sponsor's protocol ID
- Vitamin D Study Trial
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No