Regime for Vitamin D Maintenance in Post-Operative Patients

NCT06708741 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-3998
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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.

  12 months after initiation

• functional outcome measures at 3-months post-intervention

  3-months after intiation

• functional outcome measures at 6-months post-intervention

  6 months after initiation

• functional outcome measures at 12-months post-intervention

  12 months after initiation

Study Arms (2)

Vitamin D supplementation

EXPERIMENTAL

High dose oral vitamin D supplementation (50,000 IU/once a month)

Drug: Vitamin D

Standard-of-care Arm

NO INTERVENTION

standard of care arm where vitamin D levels are not actively acted upon

Interventions

Vitamin D DRUG

High dose oral vitamin D supplementation (50,000 IU/once per month)

Also known as: D-cure

Vitamin D supplementation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sengkang General Hospital: lead
• Hyphens Pharma Pte Ltd: collaborator

Study Sites (1)

Sengkang General Hospital

Singapore, Singapore, 544886, Singapore

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Frederick H Koh, FRCS, PhD

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick H Koh, FRCS, PhD

CONTACT

6930 6000; frederick.koh.h.x@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Colorectal Surgeon

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 27, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)