Vitamin D maintenance plan after major surgery

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

This trial will see if taking a monthly vitamin D dose instead of the usual maintenance schedule helps keep vitamin D levels and supports muscle recovery in adults (21–65) after major surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Sengkang General Hospital (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT06708741 on ClinicalTrials.gov

What this trial studies

This is a randomized Phase 3 trial at Sengkang General Hospital in Singapore enrolling adults 21–65 who had major surgery and have serum 25-hydroxyvitamin D levels of 30–50 ng/mL at 4–6 weeks post-op. Participants will be randomized to a monthly high-dose oral vitamin D maintenance regimen versus standard-of-care maintenance, with periodic blood tests to track vitamin D levels and clinical measures of muscle function and recovery. Key exclusions include chronic kidney disease or end-stage renal failure, hyperparathyroidism, history of kidney stones, non-ambulatory status, and allergy to high-dose vitamin D formulations. The trial uses an FDA-approved vitamin D formulation supplied by a non-U.S. manufacturer and is sponsored by Sengkang General Hospital with industry collaboration.

Who should consider this trial

Good fit: Adults aged 21–65 who underwent a major operation, are independently ambulatory, can provide consent, agree to take vitamin D supplements, and have 25-hydroxyvitamin D levels of 30–50 ng/mL at 4–6 weeks after surgery.

Not a fit: Patients with chronic kidney disease, hyperparathyroidism, prior kidney stones, non-ambulatory status, or known allergy to high-dose vitamin D are excluded and unlikely to gain benefit from this regimen.

Why it matters

Potential benefit: If successful, this could offer a simpler, less frequent vitamin D maintenance option that preserves vitamin D status and may improve muscle recovery after major surgery.

How similar studies have performed: High-dose vitamin D repletion has been used successfully in short prehabilitation programs to speed vitamin D recovery and support muscle gain, but monthly maintenance dosing after surgery has not been extensively tested in large randomized trials.

Eligibility criteria

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

Where this trial is running

Singapore, Singapore

• Sengkang General Hospital — Singapore, Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Frederick H Koh, FRCS, PhD — Sengkang General Hospital
• Study coordinator: Frederick H Koh, FRCS, PhD

Conditions Sarcopenia