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Intestinal FailureNCT06283615

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

A study testing Vitamin D in people with Intestinal Failure, run by Jinling Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Intestinal Failure
What is being tested?
Vitamin D
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
12 Mar 2024to 30 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study
  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinying Wang

    Nanning, Jiangsu, 210002

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Vitamin D
Keywords
Vitamin D, Quality of life, Muscle function, Chronic intestinal failure
Medical subject headings
Intestinal Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

    Also called Vitamin D2

    Vitamin D2 injection

Study groups in NCT06283615
Study groupRoleWhat they receive
Vitamin DExperimentalExperimental 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.
Receives: Drug: Vitamin D
ControlNo interventionControl group: received appearance-matched placebo plus standard care, no additional vitamin D intervention therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 12 weeks

  2. 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)

    Measured: up to 12 weeks

Secondary outcomes (6)

  1. Serum vitamin D levels

    Serum 25 hydroxyvitamin D levels

    Measured: up to 12 weeks

  2. 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.

    Measured: up to 12 weeks

  3. Bone mineral density

    Bone mineral density by DXA

    Measured: up to 12 weeks

  4. Thyroid and parathyroid-related hormones

    Including surum total triiodothyroxine, total tetraiodothyroxine, free triiodothyronine, free tetraiodothyroxine, thyroid stimulating hormone, parathyroid hormone and calcitonin.

    Measured: up to 12 weeks

  5. Nutritional status indicators

    Including body weight (kg), serum albumin (g/L) and prealbumin (mg/L) levels.

    Measured: up to 12 weeks

  6. 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.

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start12 Mar 2024
  3. Primary completion30 Mar 2025
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06283615
Sponsor's protocol ID
2024-01-01
Status last verified
Jul 2025
First submitted
18 Jan 2024
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30172658

  • 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.

    PubMed 25598110

  • 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.

    PubMed 21324480

  • 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.

    PubMed 24119980

  • 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.

    PubMed 15585788

  • 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.

    PubMed 34161622

  • 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.

    PubMed 24633203

  • 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.

    PubMed 31823437

  • 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.

    PubMed 25347160

  • 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.

    PubMed 41449463

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D in people with Intestinal Failure, run by Jinling Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life score (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06283615, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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