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Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: received placebo plus standard care, no additional vitamin D intervention therapy. Vitamin D group: In addition to the standard care, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
The primary and secondary outcomes will be collected.
Eligible patients with chronic intestinal failure/insufficiency were randomly assigned to one of two groups, Vitamin D group and Control group. Control group: received placebo plus standard care, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
The primary and secondary outcomes will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Experimental group: In addition to conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks. |
|
| Control | No Intervention | Control group: received appearance-matched placebo plus standard care, no additional vitamin D intervention therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D2 injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 12-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life. | up to 12 weeks |
| Muscle function status | Including hand grip strength(kg); Appendicular skeletal muscle mass index (ASMI) = limb muscle mass (kg)/height (m)2ï¼›6 meters walking speed(m/s) | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum vitamin D levels | Serum 25 hydroxyvitamin D levels | up to 12 weeks |
| Hepatic and renal function | Liver function includes the following indicators: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), direct and indirect bilirubin, γ-glutamyltranspeptidase (γ-GT) and alkaline phosphatase (ALP). Kidney function includes the following indicators: serum creatinine and blood urea nitrogen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinying Wang, MD | Jinling Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinying Wang | Nanning | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30172658 | Background | Pironi L, Corcos O, Forbes A, Holst M, Joly F, Jonkers C, Klek S, Lal S, Blaser AR, Rollins KE, Sasdelli AS, Shaffer J, Van Gossum A, Wanten G, Zanfi C, Lobo DN; ESPEN Acute and Chronic Intestinal Failure Special Interest Groups. Intestinal failure in adults: Recommendations from the ESPEN expert groups. Clin Nutr. 2018 Dec;37(6 Pt A):1798-1809. doi: 10.1016/j.clnu.2018.07.036. Epub 2018 Aug 18. | |
| 25598110 |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| up to 12 weeks |
| Bone mineral density | Bone mineral density by DXA | up to 12 weeks |
| Thyroid and parathyroid-related hormones | Including surum total triiodothyroxine, total tetraiodothyroxine, free triiodothyronine, free tetraiodothyroxine, thyroid stimulating hormone, parathyroid hormone and calcitonin. | up to 12 weeks |
| Nutritional status indicators | Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels. | up to 12 weeks |
| Number of participants with treatment-related adverse events | Occurrence of hypercalcemia and hyperphosphatemia during intervention and follow-up. The blood calcium concentration > 2.75 mmol/L is called hypercalcemia. Normal human blood phosphorus concentration is relatively stable (normal reference value 0.87~1.45mmol/ L), when the determination result is greater than the normal reference value of 1.45mmol/ L, it can be diagnosed as hyperphosphatemia. Occurrences of kidney stones during intervention and follow-up. Kidney stones are examined by ultrasound. Incidence of fall-related fractures during intervention and follow-up. | up to 12 weeks |
| Background |
| Khan FA, Fisher JG, Bairdain S, Sparks EA, Zurakowski D, Modi BP, Duggan C, Jaksic T. Metabolic bone disease in pediatric intestinal failure patients: prevalence and risk factors. J Pediatr Surg. 2015 Jan;50(1):136-9. doi: 10.1016/j.jpedsurg.2014.10.010. Epub 2014 Oct 17. |
| 21324480 | Background | Yang CF, Duro D, Zurakowski D, Lee M, Jaksic T, Duggan C. High prevalence of multiple micronutrient deficiencies in children with intestinal failure: a longitudinal study. J Pediatr. 2011 Jul;159(1):39-44.e1. doi: 10.1016/j.jpeds.2010.12.049. Epub 2011 Feb 16. |
| 24119980 | Background | Reid IR, Bolland MJ, Grey A. Effects of vitamin D supplements on bone mineral density: a systematic review and meta-analysis. Lancet. 2014 Jan 11;383(9912):146-55. doi: 10.1016/S0140-6736(13)61647-5. Epub 2013 Oct 11. |
| 15585788 | Background | Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and cardiovascular disease. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1678S-88S. doi: 10.1093/ajcn/80.6.1678S. |
| 34161622 | Background | Lepus CA, Samela K, Emerick KM, Mokha JS. Vitamin D status in children with intestinal failure who have achieved enteral autonomy. Nutr Clin Pract. 2021 Dec;36(6):1284-1289. doi: 10.1002/ncp.10685. Epub 2021 Jun 23. |
| 24633203 | Background | Wozniak LJ, Bechtold HM, Reyen LE, Hall TR, Vargas JH. Vitamin D deficiency in children with intestinal failure receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2015 May;39(4):471-5. doi: 10.1177/0148607114527135. Epub 2014 Mar 14. |
| 31823437 | Background | Allan PJ, Lal S. Metabolic bone diseases in intestinal failure. J Hum Nutr Diet. 2020 Jun;33(3):423-430. doi: 10.1111/jhn.12726. Epub 2019 Dec 11. |
| 25347160 | Background | Diamanti A, Capriati T, Cardile S, Benedetti S, Francalanci P, Elia D. Fat-soluble vitamin deficiency in children with intestinal failure receiving home parenteral nutrition. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):e46. doi: 10.1097/MPG.0000000000000508. No abstract available. |
| 41449463 | Derived | Gao X, Liu S, Zhang Y, Xia Y, Liu S, Qi X, Xiao Y, Zhu M, Sun G, Gao T, Zhang L, Wang X. Effect of vitamin D supplementation on skeletal muscle function and quality of life in patients with chronic intestinal failure: a randomized controlled trial : Clean version. J Transl Med. 2025 Dec 25;24(1):221. doi: 10.1186/s12967-025-07607-8. |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |