Sengkang General Hospital
Singapore, 544886
Location status: Recruiting
NCT Number: NCT06708741
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.
Interested in participating?
Request Info21 year–65 year
All sexes
Interventional
Phase 3
Singapore, 544886
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High dose oral vitamin D supplementation (50,000 IU/once per month)
Other names: D-cure
Time frame: 3 months after initiation
serum 25-hydroxyvitamin D levels at 3-months post-intervention
Time frame: 6 months after initiation
serum 25-hydroxyvitamin D levels compared to SOC at 6-months post-intervention.
Time frame: 12 months after initiation
serum 25-hydroxyvitamin D levels compared to SOC at 12-months post-intervention.
Time frame: 3-months after intiation
functional outcome measures at 3-months post-intervention
Time frame: 6 months after initiation
functional outcome measures at 6-months post-intervention
Time frame: 12 months after initiation
functional outcome measures at 12-months post-intervention
Time frame: 3 months after intiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention
Time frame: 6 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention
Time frame: 12 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention
Time frame: 3 months after intiation
quality of life (EQ5D-3L) at 3-months post-intervention
Time frame: 6 months after initiation
quality of life (EQ5D-3L) at 6-months post-intervention
Time frame: 12 months after initiation
quality of life (EQ5D-3L) at 12-months post-intervention
Contact information is provided by the study sponsor or research team.
Sengkang General Hospital
Other
Regime for Vitamin D Maintenance in Post-Operative Patients (D-ECISIVE) Randomized Controlled Trial
Acronym: D-ECISIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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