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 Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial
Glenys Shu Wei Quak1orcid, James Jia Dong Wang1orcid, Candy Yap2orcid, Olivia Soh2orcid, Olivia Wong3orcid, Cherie Tong2,4orcid, Phoebe Tay2,4orcid, Hui-Bing Lee2,4orcid, Shi-Min Mah2,5orcid, Frederick H. Koh1,2,6,7orcid
Annals of Coloproctology 2026;42(3):364-371.
DOI: https://doi.org/10.3393/ac.2025.01179.0168
Published online: June 25, 2026

1Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore

2SingHealth Duke-NUS Muscle Health Programme, SingHealth Duke-NUS Medical School, Singapore

3Department of Pharmacy, Sengkang General Hospital, Singapore

4Department of Dietetics, Sengkang General Hospital, Singapore

5Department of Physiotherapy, Sengkang General Hospital, Singapore

6Colorectal Service, Department of General Surgery, Sengkang General Hospital, Singapore

7Yong Loo Lin School of Medicine, National University of Singapore, Singapore

Correspondence to: Frederick H. Koh, MBBS, MMed (Surg), FRCS, PhD Colorectal Service, Department of Colorectal Surgery, Sengkang General Hospital, 110 Sengkang East Way, Singapore 544886 Email: frederickkohhx@gmail.com
• Received: October 2, 2025   • Revised: December 13, 2025   • Accepted: December 28, 2025

© 2026 The Korean Society of Coloproctology

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • Background
    Vitamin D plays a critical role in maintaining calcium and phosphate homeostasis, muscle health, and postoperative recovery. Patients undergoing surgery face an increased risk of vitamin D insufficiency because of reduced sun exposure, altered nutritional intake, and preexisting deficiencies, factors that may compromise muscle function and impair recovery and quality of life. However, there is currently no standardized protocol for postoperative vitamin D maintenance. Therefore, this study aims to evaluate whether monthly high-dose vitamin D supplementation (50,000 IU) maintains serum vitamin D levels and improves postoperative muscle function and quality of life compared with standard care.
  • Study design
    This single-center, open-label, randomized controlled trial will recruit adults aged 21 to 65 years who have undergone major surgery and have serum 25-hydroxyvitamin D levels between 30 and 50 ng/mL at 4 to 6 weeks postoperatively. Participants will be randomly assigned in a 1:1 ratio to receive either monthly high-dose vitamin D supplementation (50,000 IU cholecalciferol) for 6 months or standard postoperative care without routine vitamin D supplementation. Outcome assessors will be blinded to group allocation. The primary outcome is maintenance of serum 25-hydroxyvitamin D levels at 3 months after the intervention. Secondary outcomes include serum vitamin D levels at 6 months; assessments of muscle function, including handgrip strength, 6-minute walk test, and 5 times chair stand test; evaluations of muscle quality using the intramuscular adipose tissue index; and quality of life measured by the EuroQoL 5-dimension 3-level (EQ-5D-3L) instrument.
  • Outcome
    This study will provide evidence on whether monthly high-dose vitamin D supplementation supports muscle recovery and quality of life in postoperative patients. The findings may help establish standardized guidelines for postoperative vitamin D maintenance and inform future supplementation strategies in surgical populations.
  • Trial registration
    ClinicalTrials.gov identifier: NCT06708741. Registered on November 26, 2024.
  • Keywords: Vitamin D deficiency; Muscle health; Sarcopenia; Quality of life; Randomized controlled trial
Vitamin D is a vital nutrient that plays a crucial role in regulating calcium and phosphate homeostasis, processes that are essential for maintaining bone health and muscle function [1]. It facilitates intestinal absorption of calcium and phosphate; therefore, deficiency leads to reduced serum calcium levels, which stimulate parathyroid hormone secretion to promote bone resorption in an attempt to restore calcium balance, ultimately resulting in bone demineralization and muscle weakness [2].
Beyond its well-established role in bone metabolism, vitamin D is increasingly recognized for its importance in muscle health, as adequate levels contribute to optimal muscle recovery, strength, and functional performance [3, 4]. Given this close relationship between vitamin D status and muscle function, objective assessment of muscle quality is essential for evaluating recovery and functional outcomes. To this end, emerging technologies, such as ultrasound elastography, magnetic resonance imaging (MRI)-based muscle composition analysis, and bioelectrical impedance vector analysis, are increasingly utilized in both research and clinical settings [5]. These methods provide noninvasive, objective measures of muscle architecture, density, and functional status.
In the postoperative setting, muscle health is particularly important, as impaired muscle recovery can lead to reduced functional capacity, prolonged rehabilitation, and diminished quality of life [6]. Postoperative patients are often at heightened risk of vitamin D insufficiency or deficiency due to limited sun exposure, nutritional deficits, and preexisting low baseline levels [7]. Hence, these patients may experience muscle weakness through vitamin D–related calcium-phosphate imbalance as well as direct effects on muscle cells [8]. Vitamin D receptors are expressed in muscle tissue; therefore, deficiency impairs muscle protein synthesis and mitochondrial function, leading to muscle atrophy and fatigue [9].
Patients with suboptimal vitamin D levels after surgery also face a higher risk of delayed recovery, compromised muscle strength, and increased susceptibility to infections, underscoring the need for effective strategies to maintain adequate vitamin D levels during the postoperative period [10]. A study by Hajimohammadebrahim-Ketabforoush et al. [11] reported significantly shorter mean intensive care unit stays and overall hospital length of stay among patients receiving vitamin D supplementation. Additionally, a trial conducted by Naguib et al. [12] supported these findings and demonstrated significantly lower rates of hospital-acquired infection in the vitamin D intervention group.
Despite the importance of vitamin D in postoperative recovery, there is currently no standardized protocol for vitamin D maintenance in this population [13]. Existing guidelines primarily focus on repletion strategies for deficiency but provide limited recommendations for long-term maintenance, particularly in the context of major operations such as lung resection, colectomy, hysterectomy, and total joint replacement procedures [14]. This lack of consensus creates a significant gap in care, leaving clinicians without clear guidance regarding optimal dosage, frequency, and duration of vitamin D supplementation for postoperative patients. Furthermore, the kinetics of serum vitamin D decline following surgery remain poorly understood, representing a critical limitation in managing recovery from acute physiological stress [15].
To address these unmet needs, the D-ECISIVE trial (ClinicalTrials.gov identifier: NCT06708741) seeks to evaluate whether monthly high-dose vitamin D supplementation (50,000 IU) provides superior maintenance of serum vitamin D levels compared to standard care. The recommended regimen for treatment of vitamin D insufficiency or deficiency is 50,000 IU weekly for 8 weeks, whereas the recommended preventive dose is 25,000 IU monthly [16]. Because patients undergoing major surgery are expected to experience increased physiological demands during postoperative recovery and rehabilitation, a monthly dose of 50,000 IU was proposed to support recovery while avoiding overtreatment [17].
This study will assess the effects of high-dose supplementation on functional recovery, muscle quality, and overall quality of life compared with standard-of-care practice. In addition, it provides an opportunity to address a critical knowledge gap by monitoring the rate of serum vitamin D decline in the control group. Potential benefits of high-dose supplementation include convenience, improved adherence, and sustained serum vitamin D levels, whereas potential risks include hypercalcemia, nephrolithiasis, and theoretical cardiovascular concerns, all of which will be closely monitored in this trial. Ultimately, the results of this study may provide clinically relevant data to refine postoperative care and support the development of evidence-based guidelines for vitamin D maintenance.
The primary objective of this study is to assess the efficacy of monthly high-dose vitamin D supplementation (50,000 IU) in maintaining serum 25-hydroxyvitamin D levels at 3 months after the intervention, compared with standard care. Secondary objectives include evaluating the maintenance effect on serum 25-hydroxyvitamin D levels at 6 months after intervention, assessing improvements in muscle function using measures such as handgrip strength, 6-minute walk test (6MWT), and 5 times chair stand test, and examining muscle quality through the intramuscular adipose tissue (IMAT) index [18]. In addition, the trial will assess health-related quality of life using the EuroQoL 5-dimension 3-level (EQ-5D-3L) instrument and determine the rate of vitamin D reduction in the control group, which may help inform future supplementation strategies for postoperative patients [19].
Trial design
The D-ECISIVE trial is a single-center, open-label randomized controlled trial designed to evaluate the effects of monthly high-dose vitamin D supplementation on postoperative muscle recovery and quality of life. Participants will be randomized in a 1:1 ratio to receive either high-dose monthly vitamin D supplementation or standard care. Block randomization will be performed to ensure balanced group sizes throughout the trial, using publicly available computer-generated software at the start of the study [20]. Allocation will be conducted via phone call to the main research administrative staff member, who is not involved in patient evaluation. Although participants and physicians will not be blinded because of the objective nature of the primary outcome, data collectors and staff involved in patient assessments will remain blinded to group allocation. The assessment, intervention, and follow-up processes are illustrated in Fig. 1. The study protocol has been reported in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Clinical Interventional Trials) guidelines (Fig. 2).
Ethics statement
This study was approved by the SingHealth Centralised Institutional Review Board (No. 2024-3998).
Study setting
The D-ECISIVE trial will be conducted in the Department of General Surgery at Sengkang General Hospital and will recruit postoperative patients who have undergone major surgery. Participants will be recruited during postoperative follow-up visits in surgical wards or outpatient clinics.
Eligibility criteria
Participants will include individuals aged 21 to 65 years who have undergone major surgery and meet at least 2 of the following 3 criteria: the total operation duration, including anesthesia and surgery, is at least 4 hours; the average length of hospital stay is at least 4 days; and the procedure is classified as Singapore’s Table of Surgical Procedures (TOSP) category 4a or above. Eligible participants must have a normal serum 25-hydroxyvitamin D level between 30 and 50 ng/mL at 4 to 6 weeks postoperatively and possess the capacity to provide informed consent. Patients who have undergone minor procedures (TOSP code <4a), have chronic kidney disease or end-stage renal failure, hyperparathyroidism, a history of kidney or ureteric stones, are nonambulatory, or are allergic to high-dose vitamin D formulations will be excluded. Pregnant patients will also be excluded. Patients using contraception may be included initially but will be withdrawn from the study if pregnancy is subsequently confirmed and will be classified as dropouts.
Interventions
Participants in the intervention group will receive 50,000 IU of oral cholecalciferol (D-Cure, Hyphens Pharma) once monthly for 6 months, as approved by the US Food and Drug Administration (FDA). Participants in the control group will receive standard care without high-dose vitamin D maintenance. Study visits will include a screening phase during which serum 25-hydroxyvitamin D levels, functional assessments, and EQ-5D-3L surveys will be conducted. Follow-up visits will occur at 3 and 6 months, during which serum vitamin D levels, muscle function, quality of life, and muscle quality assessments will be repeated.
Outcomes
The primary outcome of the study is maintenance of serum 25-hydroxyvitamin D levels at or above 30 ng/mL at 3 months after intervention. Secondary outcomes include serum 25-hydroxyvitamin D levels at 6 months after intervention, assessments of muscle function, and evaluation of health-related quality of life using the EQ-5D-3L instrument. Safety outcomes, including the incidence of hypercalcemia and adverse events related to vitamin D supplementation, will also be monitored.
Sample size calculation
The sample size calculation was based on the assumption that 90% of participants in the intervention group and 70% of participants in the control group will maintain serum 25-hydroxyvitamin D levels above 30 ng/mL at 3 months after intervention. With a 2-sided significance level of 5% and a statistical power of 80%, and after accounting for a 10% dropout rate, the study requires 50 participants per group, resulting in a total sample size of 100 participants.
Data collection, management, and analysis
Data will be collected at screening and during follow-up visits at 3 and 6 months after intervention. To ensure data quality, assessors will receive standardized training, and duplicate measurements will be performed where applicable. All data will be stored securely under lock and key with password-protected access restricted exclusively to the study team. Data monitoring audits will be conducted at each scheduled interim analysis. All data will be entered prospectively, with raw data linked only to patient identification numbers and therefore deidentified. Personal identifiers will be retained solely by the principal investigator under password protection and will be accessed only in the event of an adverse drug-related event.
Participants may withdraw from the study at any time without providing a reason. At the time of discontinuation, serum 25-hydroxyvitamin D levels will be measured to determine eligibility for continued clinical follow-up. Current EQ-5D-3L and functional assessments will also be completed. Quality of life will be measured using the EQ-5D-3L, and muscle function will be assessed using validated tools including handgrip strength measured with a calibrated dynamometer [21], gait speed over a 10-m walk [22], the 6MWT [23], and the 5 times chair stand test [24]. These measures are widely used functional assessments with strong correlations to postoperative recovery and mobility status.
Muscle quality will also be evaluated using a combination of quantitative and imaging-based assessments. This includes the MuscleSound system (MuscleSound Inc), which utilizes ultrasound technology combined with proprietary software to quantify IMAT and estimate muscle glycogen and density levels [25]. The IMAT index derived from MuscleSound provides a noninvasive, validated marker of muscle composition and quality [18]. In addition, dual-energy x-ray absorptiometry (DEXA) will be used to assess T-scores and overall body composition, providing a secondary reference for muscle mass and bone health [26].
If a participant chooses to withdraw from the study, participation will be terminated, and the most recently recorded data will be used for analysis.
Statistical analysis
Categorical variables will be presented as percentages, and continuous variables will be presented as means with standard deviations. Statistical analyses will include descriptive statistics for baseline characteristics, Fisher exact test for categorical variables, and t-tests, analysis of variance, and analysis of covariance for continuous variables. Multivariate regression analyses will be performed to adjust for potential confounders, including established confounding factors and baseline characteristic differences associated with a P-value of <0.1. Interim analyses will be conducted at 25%, 50%, and 75% recruitment milestones to assess safety and efficacy.
Trial status
This study is being conducted according to protocol version 2.0, dated May 5, 2025. Recruitment of participants began on January 1, 2026, and expected to be completed by December 31, 2026.
Muscle health plays a crucial role in perioperative recovery by influencing mobility, postoperative complications, and overall functional outcomes [27]. Surgical stress, immobilization, and inflammatory responses contribute to muscle catabolism, which can lead to sarcopenia and delayed rehabilitation [28]. Vitamin D is essential for skeletal muscle function because it regulates calcium homeostasis, influences muscle protein synthesis, and modulates inflammatory pathways [29]. Vitamin D deficiency has been associated with reduced muscle strength, impaired recovery, and increased fall risk across diverse patient populations [30].
The D-ECISIVE trial seeks to address this gap by evaluating whether monthly high-dose vitamin D supplementation can enhance postoperative muscle recovery and quality of life. The selected regimen of 50,000 IU administered monthly balances efficacy and adherence, as less frequent dosing reduces pill burden while maintaining adequate serum vitamin D concentrations. Compared with a daily 1,000 IU regimen, this strategy may improve long-term compliance and support more stable physiological adaptation, particularly in populations with a high prevalence of baseline vitamin D deficiency.
To evaluate muscle health, this study will employ both functional and muscle quality–based assessments. Muscle function will be assessed using validated clinical tools, including handgrip strength, gait speed, the 6MWT, and the 5 times chair stand test. These measures are widely used in comparable studies because of their simplicity, reproducibility, and strong correlation with clinically meaningful outcomes. For example, studies by Beaudart et al. [31] and Cruz-Jentoft et al. [32] have applied similar assessment tools in sarcopenia and postoperative populations.
In contrast to conventional imaging modalities such as computed tomography or MRI, which are resource-intensive and typically limited to cross-sectional evaluation, this study employs the MuscleSound system to assess muscle quality. This portable, ultrasound-based technology enables repeated bedside assessments and provides additional insights into muscle composition [33]. The MuscleSound device quantifies several parameters, including IMAT, muscle density, and estimated glycogen content [34]. Among these measures, IMAT represents a key indicator of muscle quality, as higher IMAT values are associated with reduced muscle function, poorer physical performance, and increased metabolic risk. This metric therefore serves as a valuable noninvasive surrogate for muscle degeneration and fatty infiltration, which are particularly relevant in postoperative populations [35]. Compared with studies that rely solely on muscle mass measurements such as DEXA or exclusively on functional tests, the combined use of structural (IMAT) and performance-based assessments in this study provides a more comprehensive evaluation of recovery. Additionally, the ultrasound-based approach reduces radiation exposure and is more feasible for repeated follow-up assessments.
Beyond efficacy, this study will also assess the safety profile of high-dose vitamin D supplementation and evaluate the rate of decline in vitamin D levels among participants in the control group. Characterizing this decline is important for informing future supplementation strategies; if a clinically significant reduction is observed, adjustments to dosing frequency or intensity may be necessary to optimize postoperative outcomes.
Muscle health has profound long-term implications for aging, frailty, and overall quality of life. Maintaining adequate vitamin D levels after surgery may help prevent muscle deterioration, reduce hospital readmissions, and promote sustained functional independence. Nevertheless, muscle recovery is multifactorial and depends not only on vitamin D status but also on adequate protein intake, resistance-based exercise, and comprehensive nutritional support [36].
In addition to muscle-related outcomes, this study evaluates health-related quality of life using the EQ-5D-3L instrument. Although the EQ-5D-5L is increasingly used in Western settings, the three-level version was selected because of its more established utility value sets for quality-adjusted life year calculations [37]. The EQ-5D-3L facilitates cost-effectiveness and health economic analyses across both Western and Asian contexts, including Singapore [38]. In contrast, the EQ-5D-5L currently lacks validated local value sets, limiting its suitability for implementation-focused studies [39]. This methodological choice ensures consistency with prior trials and supports future translational work involving economic modeling and health policy evaluation.
By addressing these methodological and clinical considerations, the D-ECISIVE trial aims to generate critical insights into the role of vitamin D supplementation in perioperative care, thereby informing future clinical guidelines and optimizing recovery strategies for surgical patients.

Conflict of interest

Frederick H. Koh is an editorial board member of this journal, but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflict of interest relevant to this article was reported.

Funding

The study is funded in part by Hyphens Pharma through an investigator-initiated study grant. The funding organization is not involved in the design of the study, data collection, analysis, interpretation, or manuscript writing.

Author contributions

Conceptualization: CY, OS, OW, CT, PT, HBL, SMM, FHK; Funding acquisition: FHK; Methodology: GSWQ, JJDW, FHK; Project administration: FHK; Writing–original draft: all authors; Writing–review & editing: GSWQ, JJDW, FHK. All authors read and approved the final manuscript.

Fig. 1.
Flowchart of assessment, intervention, and follow-up.
ac-2025-01179-0168f1.jpg
Fig. 2.
Study protocol following the SPIRIT (Standard Protocol Items: Recommendations for Clinical Interventional Trials) guidelines. EQ-5D-3L, EuroQoL 5-dimension 3-level; 6MWT, 6-minute walk test.
ac-2025-01179-0168f2.jpg
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        Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial
        Ann Coloproctol. 2026;42(3):364-371.   Published online June 25, 2026
        DOI: https://doi.org/10.3393/ac.2025.01179.0168
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      Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial
      Image Image
      Fig. 1. Flowchart of assessment, intervention, and follow-up.
      Fig. 2. Study protocol following the SPIRIT (Standard Protocol Items: Recommendations for Clinical Interventional Trials) guidelines. EQ-5D-3L, EuroQoL 5-dimension 3-level; 6MWT, 6-minute walk test.

      Fig. 1.

      Fig. 2.

      Vitamin D maintenance in postoperative patients (D-ECISIVE): a study protocol for a randomized controlled trial
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