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The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In the intervention group, low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day. |
|
| Control | Active Comparator | In the control group, low-protein diet (0.6-0.8g protein/kg body weight/day) and the target energy intake of 25-30kcal/kg body weight/day will be prescribed for 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-protein diet + Ketosteril | Combination Product | low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day. |
| Measure | Description | Time Frame |
|---|---|---|
| skeletal muscle mass index (SMI) | SMI=skeletal muscle weight/(height×height),the muscle weight with the unit of kg and square of height with the unit of m2 will be combined to report SMI in kg/m^2 | six months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| changes in eGFR(ml/min/1.73m2) | From baseline to the 6th month, changes in eGFR(ml/min/1.73m2) | six months after the intervention |
| serum albumin(g/l) | From baseline to the 6th month, changes in serum albumin(g/l) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengjing Wang, PhD, MD | Contact | 02152889393 | fiyona27@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, PhD, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital, Fudan university | Recruiting | Shanghai | 200040 | China |
Data will be made available upon request pending
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| C048995 | ketosteril |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| low-protein diet | Dietary Supplement | low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day. |
|
| six months after the intervention |
| grip strength(kg) | From baseline to the 6th month,changes in grip strength(kg) | six months after the intervention |
| BMI(kg/m2) | From baseline to the 6th month,changes in BMI(kg/m2) | six months after the intervention |
| 6m walking speed(s) | From baseline to the 6th month,changes in 6m walking speed(s) | six months after the intervention |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |