Regime for Vitamin D Maintenance in Post-Operative Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Vitamin D.
- Кому может быть актуально
- Состояния в реестре: Sarcopenia. Базовые параметры: 21 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Сингапур
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Regime for Vitamin D Maintenance in Post-Operative Patients (D-ECISIVE) Randomized Controlled Trial
Обзор
Vitamin D plays a significant part calcium and phosphate haemostasis, thus, intrinsically critical for bone health. Increasing evidence also reveal that insufficient serum vitamin D levels also result in poor muscle health with such individuals having a compromised muscle building potential (4 times slower muscle building). Muscle health is a critical component of a post-surgical patient recovery, with impaired muscle function leading to reduced functional ability, resulting in a poorer quality of life. Poor muscle health also has negative repercussion on survivability, with reduced overall, and disease-specific survival, especially shown in cancer patients. Thus, maintenance of vitamin D levels post-surgery may be more critical than previously thought.
Подробное описание
This study is performed in Singapore (outside the US) and the medication, while it is a FDA approved medication, is not manufactured in the US for the trial purpose and the indications of use in this trial is not new.
The investigators would be recruiting patients aged 21-65 years who have undergone major surgery (defined by the NICE criteria) and who are able to provide informed consent, accept to take vitamin D supplements post-operatively and have their serum vitamin D levels checked periodically.
The investigators will excluded patients who have undergone minor procedures (Table code \<4a), those who have a history of chronic kidney disease/end staged renal failure, known hyperparathyroidism, are non-ambulatory independently and have had known allergies to the commercially available high dose vitamin D formulations.
High dose oral vitamin D supplementation (50,000 IU/week for 8 weeks) is the current recommended dose for individuals with vitamin D insufficiency of deficiency and is currently being used for some prehabilitation programmes due to the quick repletion of vitamin D levels to improve muscle gain during the short prehabilitation window prior to surgery.
Using the same dose once a month would provide a significantly less vitamin D supplementation, especially with individuals who have had their vitamin D levels repleted in the preoperative phase. This will be compared against a control who are randomised to standard-of-care (SOC) where high dose vitamin D maintenance is not prescribed.
The unmet clinical need is the still unknown, unstandardised vitamin D supplementation regime. There are current no clinical consensus on vitamin D supplementation after patients who have undergone major surgery.
Вмешательства
- Препарат Vitamin D
High dose oral vitamin D supplementation (50,000 IU/once per month)
Первичные конечные точки
- serum 25-hydroxyvitamin D levels at 3-months post-intervention [Срок оценки: 3 months after initiation]
Вторичные конечные точки (11)
- serum 25-hydroxyvitamin D levels compared to SOC at 6-months post-intervention. [Срок оценки: 6 months after initiation]
- serum 25-hydroxyvitamin D levels compared to SOC at 12-months post-intervention. [Срок оценки: 12 months after initiation]
- functional outcome measures at 3-months post-intervention [Срок оценки: 3-months after intiation]
- functional outcome measures at 6-months post-intervention [Срок оценки: 6 months after initiation]
- functional outcome measures at 12-months post-intervention [Срок оценки: 12 months after initiation]
- muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention [Срок оценки: 3 months after intiation]
- muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention [Срок оценки: 6 months after initiation]
- muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention [Срок оценки: 12 months after initiation]
- quality of life (EQ5D-3L) at 3-months post-intervention [Срок оценки: 3 months after intiation]
- quality of life (EQ5D-3L) at 6-months post-intervention [Срок оценки: 6 months after initiation]
- quality of life (EQ5D-3L) at 12-months post-intervention [Срок оценки: 12 months after initiation]
Критерии участия
Критерии включения
- Serum 25-hydroxyvitamin D levels between 30-50ng/ml at 4-6 weeks after operation
- aged 21-65 years
- ability to provide informed consent
- accepts to take vitamin D supplements post-operatively and
- have their serum vitamin D levels checked periodically.
Критерии исключения
- They have undergone minor procedures (Table code <4a)
- have a history of chronic kidney disease/end staged renal failure
- have previous history of ureteric/kidney stones
- known hyperparathyroidism
- are non-ambulatory independently
- have had known allergies to the commercially available high dose vitamin D formulations.
- Vulnerable personnel would be excluded from the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Профилактика
Центры проведения
Сингапур · 1 центр
- Sengkang General Hospital — Singapore
Публикации
- Quak GSW, Wang JJD, Yap C, Soh O, Wong O, Tong C, Tay P, Lee HB, Mah SM, Koh FH. Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial. Ann Coloproctol. 2026 Jun;42(3):364-371. doi: 10.3393/ac.2025.01179.0168. Epub 2026 Jun 25. PMID 42392859
Идентификаторы
NCT: NCT06708741 · 2024-3998