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Intradialytic vs postdialytic oral nutrition supplement in chronic hemodialysis patients

Intradialytic versus post-dialytic oral nutritional supplementation in malnourished hemodialysis patients: A randomized controlled trial (TIMING-ONS)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260806001
Enrollment
42
Registered
2026-08-06
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition Chronic hemodialysis Intradialytic Postdialytic Oral nutritional supplement Malnutrition Chronic hemodialysis

Interventions

Patients are given ONS within 30 minutes after finishes a hemodialysis session.,Patients are given ONS within the 4 hours during the hemodialysis session.
Post-dialytic ONS,Intra-dialytic ONS

Sponsors

Division of Nephrology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Receiving maintenance hemodialysis for more than 6 months, with dialysis performed three times per week for approximately 4 hours per session 2. Adequate dialysis, defined as a delivered single pool KtV more than or equal to 1.2 3. Malnutrition Inflammation Score (MIS) more than or equal to 6, or serum albumin less than 3.8 g/dL

Exclusion criteria

Exclusion criteria: 1. Active malignancy 2. Advanced liver disease 3. Cognitive impairment 4. A history of allergy to any component of the oral nutritional supplement used in the study 5. Frequent intradialytic hypotension, defined as a nadir intradialytic systolic blood pressure (SBP) less than 90 mmHg on more than three occasions within the month before study enrollment 6. Presence of intestinal obstruction or a gastrointestinal disorder affecting nutrient absorption 7. A history of hospitalization or major surgery within 3 months before study enrollment

Design outcomes

Primary

MeasureTime frame
Change in dialysis adequacy baseline and 12-week measurement spKt/V—

Secondary

MeasureTime frame
Change in serum albumin level baseline and 12-week measurement Serum albumin,Change in Malnutrition Inflammation Score baseline and 12-week measurement MIS,Change in muscle mass baseline and 12-week measurement Bioimpedance,Change in health related quality of life baseline and 12-week measurement KDQOL SF v1.3,Change in inflammatory biomarkers baseline and 12-week measurement CRP,Safety baseline and 12-week measurement Intradialytic hypotension events—

Countries

Thailand

Contacts

Public ContactKornchanok Vareesangthip

Division of Nephrology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

kornchanok.var@mahidol.ac.th66897644513

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Oct 17, 2026