Regime for Vitamin D Maintenance in Post-Operative Patients

ConditionSarcopenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-65
SponsorSengkang General Hospital

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Vitamin D supplementationExperimental treatment 1 intervention
Group B: Standard-of-care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

serum 25-hydroxyvitamin D levels at 3-months post-intervention

serum 25-hydroxyvitamin D levels at 3-months post-intervention

Time frame
3 months after initiation

Secondary outcomes

1

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.

Time frame
6 months after initiation
2

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.

Time frame
12 months after initiation
3

functional outcome measures at 3-months post-intervention

functional outcome measures at 3-months post-intervention

Time frame
3-months after intiation
4

functional outcome measures at 6-months post-intervention

functional outcome measures at 6-months post-intervention

Time frame
6 months after initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sengkang General Hospital

Lead sponsor

Hyphens Pharma Pte Ltd

Collaborator