SarcopeniaPhase 3D-ECISIVENCT06708741
Regime for Vitamin D Maintenance in Post-Operative Patients
A Phase 3 study testing Vitamin D in people with Sarcopenia, run by Sengkang General Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, Singapore, 544886
Frederick H Koh, FRCS, PhD, 6930 6000 ext. 65, frederick.koh.h.x@singhealth.com.sg
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Vitamin D
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called D-cure
High dose oral vitamin D supplementation (50,000 IU/once per month)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | High dose oral vitamin D supplementation (50,000 IU/once a month) Receives: Drug: Vitamin D |
| Standard-of-care Arm | No intervention | standard of care arm where vitamin D levels are not actively acted upon |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D levels at 3-months post-intervention
serum 25-hydroxyvitamin D levels at 3-months post-intervention
Measured: 3 months after initiation
Secondary outcomes (11)
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.
Measured: 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.
Measured: 12 months after initiation
functional outcome measures at 3-months post-intervention
functional outcome measures at 3-months post-intervention
Measured: 3-months after intiation
functional outcome measures at 6-months post-intervention
functional outcome measures at 6-months post-intervention
Measured: 6 months after initiation
functional outcome measures at 12-months post-intervention
functional outcome measures at 12-months post-intervention
Measured: 12 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention
muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention
Measured: 3 months after intiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention
muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention
Measured: 6 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention
muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention
Measured: 12 months after initiation
quality of life (EQ5D-3L) at 3-months post-intervention
quality of life (EQ5D-3L) at 3-months post-intervention
Measured: 3 months after intiation
quality of life (EQ5D-3L) at 6-months post-intervention
quality of life (EQ5D-3L) at 6-months post-intervention
Measured: 6 months after initiation
quality of life (EQ5D-3L) at 12-months post-intervention
quality of life (EQ5D-3L) at 12-months post-intervention
Measured: 12 months after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hyphens Pharma Pte Ltd
- Responsible party
- Principal investigator, Koh Hong Xiang Frederick, Sengkang General Hospital
- Investigators
- Frederick H Koh, FRCS, PhD, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708741
- Sponsor's protocol ID
- 2024-3998
- Acronym
- D-ECISIVE
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only centrally available to the PI
Publications
Quak GSW, Wang JJD, Yap C, Soh O, Wong O, Tong C, Tay P, Lee HB, Mah SM, Koh FH. Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial. Ann Coloproctol. 2026 Jun;42(3):364-371. doi: 10.3393/ac.2025.01179.0168. Epub 2026 Jun 25.
PubMed 42392859
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regime for Vitamin D Maintenance in Post-Operative Patients (D-ECISIVE) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06708741
- Acronym / sponsor ID
- D-ECISIVE / 2024-3998
- Conditions
- Sarcopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Collaborators
- Hyphens Pharma Pte Ltd
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Drug: Vitamin DHigh dose oral vitamin D supplementation (50,000 IU/once a month) |
| Standard-of-care Arm | No intervention | –standard of care arm where vitamin D levels are not actively acted upon |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: D-cureHigh dose oral vitamin D supplementation (50,000 IU/once per month) | Drug | Vitamin D supplementation |
Primary outcome
serum 25-hydroxyvitamin D levels at 3-months post-intervention
Time frame: 3 months after initiation
serum 25-hydroxyvitamin D levels at 3-months post-intervention
11 secondary outcomes
serum 25-hydroxyvitamin D levels compared to SOC at 6-months post-intervention.
Time frame: 6 months after initiation
serum 25-hydroxyvitamin D levels compared to SOC at 12-months post-intervention.
Time frame: 12 months after initiation
functional outcome measures at 3-months post-intervention
Time frame: 3-months after intiation
functional outcome measures at 6-months post-intervention
Time frame: 6 months after initiation
functional outcome measures at 12-months post-intervention
Time frame: 12 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 3-months post-intervention
Time frame: 3 months after intiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 6-months post-intervention
Time frame: 6 months after initiation
muscle quality (Ultrasound+MuscleSound™ evaluation) at 12-months post-intervention
Time frame: 12 months after initiation
quality of life (EQ5D-3L) at 3-months post-intervention
Time frame: 3 months after intiation
quality of life (EQ5D-3L) at 6-months post-intervention
Time frame: 6 months after initiation
quality of life (EQ5D-3L) at 12-months post-intervention
Time frame: 12 months after initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 42392859Quak GSW, Wang JJD, Yap C, Soh O, Wong O, Tong C, Tay P, Lee HB, Mah SM, Koh FH. Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial. Ann Coloproctol. 2026 Jun;42(3):364-371. doi: 10.3393/ac.2025.01179.0168. Epub 2026 Jun 25.
- Individual participant dataSharing planned: No. only centrally available to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederick H Koh, FRCS, PhD principal investigator
Sengkang General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Sarcopenia, run by Sengkang General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederick H Koh, FRCS, PhD (6930 6000, frederick.koh.h.x@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25-hydroxyvitamin D levels at 3-months post-intervention (time frame: 3 months after initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.