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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

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07864662
Lead Sponsor Aga Khan University
Conditions Vitamin D 25-Hydroxylase Deficiency, Undernutrition, Neurocognitive Development
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov