Regime for Vitamin D Maintenance in Post-Operative Patients (D-ECISIVE)

Regime for Vitamin D Maintenance in Post-Operative Patients (D-ECISIVE) Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Drug: Vitamin D

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Frederick H Koh, FRCS, PhD; Phone Number: 6930 6000; Email: frederick.koh.h.x@singhealth.com.sg

Study Locations

• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 544886
      • Recruiting
      • Sengkang General Hospital
      • Contact: Frederick H Koh, FRCS, PhD; Phone Number: 65 6930 6000; Email: frederick.koh.h.x@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D supplementation; High dose oral vitamin D supplementation (50,000 IU/once a month)	Drug: Vitamin D; High dose oral vitamin D supplementation (50,000 IU/once per month); Other Names: D-cure
No Intervention: Standard-of-care Arm; standard of care arm where vitamin D levels are not actively acted upon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum 25-hydroxyvitamin D levels at 3-months post-intervention	serum 25-hydroxyvitamin D levels at 3-months post-intervention	3 months after initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum 25-hydroxyvitamin D levels compared to SOC at 6-months post-intervention.	serum 25-hydroxyvitamin D levels compared to SOC at 6-months post-intervention.	6 months after initiation
serum 25-hydroxyvitamin D levels compared to SOC at 12-months post-intervention.	serum 25-hydroxyvitamin D levels compared to SOC at 12-months post-intervention.	12 months after initiation
functional outcome measures at 3-months post-intervention	functional outcome measures at 3-months post-intervention	3-months after intiation
functional outcome measures at 6-months post-intervention	functional outcome measures at 6-months post-intervention	6 months after initiation
functional outcome measures at 12-months post-intervention	functional outcome measures at 12-months post-intervention	12 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention	muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention	3 months after intiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention	muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention	6 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention	muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention	12 months after initiation
quality of life (EQ5D-3L) at 3-months post-intervention	quality of life (EQ5D-3L) at 3-months post-intervention	3 months after intiation
quality of life (EQ5D-3L) at 6-months post-intervention	quality of life (EQ5D-3L) at 6-months post-intervention	6 months after initiation
quality of life (EQ5D-3L) at 12-months post-intervention	quality of life (EQ5D-3L) at 12-months post-intervention	12 months after initiation

Collaborators and Investigators

• Sponsor: Sengkang General Hospital
• Collaborators: Hyphens Pharma Pte Ltd
• Investigators: Principal Investigator: Frederick H Koh, FRCS, PhD, Sengkang General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Secosteroids; Vitamin D
• Other Study ID Numbers: 2024-3998

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only centrally available to the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No