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

NCT06283615 | Completed DMC

• 1 other identifier: 2024-01-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intestinal Failure

Keywords

Vitamin D; Quality of life; Muscle function; Chronic intestinal failure

Outcome Measures

Primary Outcomes (2)

• 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)2；6 meters walking speed(m/s)

  up to 12 weeks

Secondary Outcomes (6)

• Serum vitamin D levels

  up to 12 weeks

• Hepatic and renal function

  up to 12 weeks

• Bone mineral density

  up to 12 weeks

• Thyroid and parathyroid-related hormones

  up to 12 weeks

• Nutritional status indicators

  up to 12 weeks

Study Arms (2)

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.

Drug: Vitamin D

Control

NO INTERVENTION

Control group: received appearance-matched placebo plus standard care, no additional vitamin D intervention therapy.

Interventions

Vitamin D DRUG

Vitamin D2 injection

Also known as: Vitamin D2

Vitamin D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent was obtained from patients or their legal representatives for participation in this study
• Patients 18 years of age or older, under 70 years of age, chronic intestinal failure/insufficiency
• Serum 25(OH)D level \< 30.0 ng/ml
• Vital signs are stable

You may not qualify if:

• Primary hypothyroidism or parathyroidism
• Patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug
• Patients with primary diabetes
• Patients with mental illness, inability to cooperate or consciousness disorders
• Patients with contraindications of experimental drugs
• Patients with a suspected or confirmed history of substance abuse
• Immune deficiency, use of immunosuppressants and hormones
• Pregnant and lactating women
• Have taken any vitamin D supplements in the last 6 months
• Have taken any medication in the last 6 months that affects vitamin D metabolism (e.g., phenytoin, phenobarbital, rifampicin)
• Patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial
• Sponsors or investigators directly involved in the trial or their family members
• The researcher believes that there is any reason not to be accepted

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Xinying Wang

Nanning, Jiangsu, 210002, China

Location

Related Publications (9)

• 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.

  PMID: 30172658 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.

  PMID: 25598110 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.

  PMID: 21324480 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.

  PMID: 24119980 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.

  PMID: 15585788 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.

  PMID: 34161622 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.

  PMID: 24633203 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.

  PMID: 31823437 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.

  PMID: 25347160 BACKGROUND

MeSH Terms

Conditions

Intestinal Failure

Interventions

Vitamin D; Ergocalciferols

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Xinying Wang, MD

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 28, 2024
• Study Start: March 12, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)