Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency

Intestinal Failure Clinical Trial

Official title:

Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency: A Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283615
• Other study ID #: 2024-01-01
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Jinling Hospital, China
• Contact: Xuejin Gao, MD
• Phone: +86 18251937684
• Email: 547625433[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, 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.

Description:

Eligible patients with chronic intestinal failure/insufficiency were randomly assigned to one of two groups, Vitamin D group and Control group. Control group: routine treatment only, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Informed consent was obtained from patients or their legal representatives for participation in this study

2. Patients 18 years of age or older, under 70 years of age, chronic intestinal failure/insufficiency

3. Serum 25(OH)D level < 30.0 ng/ml

4. Vital signs are stable

Exclusion Criteria:

1. Those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study

2. Primary hypothyroidism or parathyroidism

3. Patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug

4. Patients with primary diabetes

5. Patients with mental illness, inability to cooperate or consciousness disorders

6. Patients with contraindications of experimental drugs

7. Patients with a suspected or confirmed history of substance abuse

8. Immune deficiency, use of immunosuppressants and hormones

9. Pregnant and lactating women

10. Have taken any vitamin D supplements in the last 6 months

11. Have taken any medication in the last 6 months that affects vitamin D metabolism (e.g., phenytoin, phenobarbital, rifampicin)

12. Patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial

13. Sponsors or investigators directly involved in the trial or their family members

14. The researcher believes that there is any reason not to be accepted

Related Conditions & MeSH terms

• Intestinal Failure

Intervention

Drug:
• Vitamin D
Vitamin D2 injection

Locations

Country	Name	City	State
China	Xinying Wang	Nanning	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Muscle function status	Including hand grip strength(kg); Appendicular skeletal muscle mass index (ASMI) = limb muscle mass (kg)/height (m)2;6 meters walking speed(m/s)	up to 12 weeks
Secondary	Serum vitamin D levels	Serum 25 hydroxyvitamin D levels	up to 12 weeks
Secondary	Hepatic and renal function	Liver function includes the following indicators: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), direct and indirect bilirubin, ?-glutamyltranspeptidase (?-GT) and alkaline phosphatase (ALP). Kidney function includes the following indicators: serum creatinine and blood urea nitrogen.	up to 12 weeks
Secondary	Bone mineral density	Bone mineral density by DXA	up to 12 weeks
Secondary	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
Secondary	Nutritional status indicators	Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels.	up to 12 weeks
Secondary	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