Crohn DiseasePhase 4NCT02704624
Effects of Supplementation of Vitamin D in Patients With Crohn's Disease
A Phase 4 study testing Vitamin D in people with Crohn Disease and Vitamin D Deficiency, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
Thus, the aim of the current study is to assess the influence of vitamin D deficiency and, consequently, of serum calcium deficiency in the body composition, muscular activity, bone mineral density, fatigue, and exercise tolerance of CD patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Crohn Disease, Vitamin D Deficiency, Fatigue
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Feb 2022
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Crohn's Disease (moderate to severe)
- Remission of Crohn's activity
- Reduced blood levels of vitamin D
Who cannot join
- Presence of other chronic concomitant disease
- Presence of other autoimmune disease
- Presence of sleep disturbance
- Abuse of alcohol and other drugs
- Pregnancy or lactation, climacteric and/or menopausal women
- Adherence to extreme diet (e.g. macrobiotic or vegetarian diet)
Show all 9Show fewer
- Celiac disease
- Presence of extensive resection of the small intestine (more than 100cm²)
- Patients undergoing vitamin D replacement for the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial
Thus, the aim of the current study is to assess the influence of vitamin D deficiency and, consequently, of serum calcium deficiency in the body composition, muscular activity, bone mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to determine the impact of vitamin D supplementation on this population.
Read the detailed description
This will be a clinical, randomized, controlled, and double-blind trial comprising a consecutive sample of 110 CD patients in remission and low serum vitamin D levels treated by the Gastroenterology team of the Inflammatory Intestinal Disease Clinic at the University Hospital (HU/CAS), Federal University of Juiz de Fora (UFJF). These patients will be divided into two groups with 55 patients each. One group will receive vitamin D supplementation (50.000 UI/week) and the other will receive placebo. Upon the approval by the Ethics Committee of the UFJF, the study aims and procedures will be previously explained to the individuals, who will sign an informed consent form.
The sample size was based on the handgrip strength test, assuming an alpha risk of 5 % and beta risk of 80 %, standard deviation of 2.5, and a difference in magnitude of 30% of response between intervention and placebo group, the sample size needed was 45 patients in each group. Therefore, considering potential losses, 55 patients will be recruited for each group, requiring a total of 110 volunteers.
Study procedure
Phase 1. Assessment All patients in the study will be subjected to the following tests: a. clinical assessment; B. biochemical assessment; c. body composition assessment/anthropometry; d. bone mineral density assessment; e. peripheral muscle strength assessment; f. fatigue assessment; g.Exercise Tolerance Testing
Clinical Assessment of the Disease The following data will be collected in the initial assessment: age, gender, CD duration, data related to the Montreal Classification (age at the time of diagnosis, disease behavior and location), glucocorticoid use and number of exacerbations in the previous year. The inflammatory activity assessment will be held according to the Harvey-Bradshaw Index, When the score is less than 5, the disease is considered to be inactive.
Biochemical Assessment The participants will be instructed to fast 12 hours prior to the blood sampling for analysis. A 5 ml venous blood sample will be collected from the patients in order to determine biochemical parameters. The University Hospital routine laboratory will analyze the venous blood, the levels of C-reactive protein (CRP), calcium, 25-hydroxyvitamin D, parathyroid hormone (PTH) and inflammatory cytokines such as Interleukins (IL) 17, IL 6 and Tumor necrosis factor alfa (TNF-α) . CRP and serum calcium are routinely evaluated in all CD patients under follow-up in the inflammatory bowel disease clinic at HU/CAS.
The following reference values will be taken into consideration regarding 25-hydroxyvitamin D: < 20ng/mL = deficiency, between 21 and 29 ng/mL = insufficiency, and > 30 ng/mL = satisfactory.
Bone Mineral Density Assessment A bone densitometer, Lunar Prodigy Primo (pr + 351035), will be used to measure the patients' bone mineral density (BMD), expressed in g/cm2, by dual-energy x-ray absorptiometry (DXA). The double-energy X-ray densitometry of the skeleton or specific sites such as the spine and the hip is based on the X-rays absorption by the calcium crystals in the bone. The lumbar spine regions between L1 and L4 and those of the total proximal femur will be assessed. The examination will be held under appropriate conditions, according to the technical quality controls. The coefficient of variation for the lumbar spine and total proximal femur will be obtained based on these results. The low BMD will be defined by the reduction greater than -2.0 standard deviations from the reference value mean of healthy individuals, adjusted according to height, age and gender (Z score), in compliance with the official positions of the International Society for Clinical Densitometry (ISCD).
Body Composition Assessment/Anthropometry The assessment will be held through the Quantum BIA (bioelectrical impedance analysis) bioimpedance device. The device is four-pole, has digital display, and provides resistance and reactance values. Total and segmental body composition parameters will be also assessed by DXA expressed in kg.
Muscle Strength Assessment The peripheral muscle strength will be assessed through the maximum voluntary handgrip strength using hand-held dynamometry (HHD), which consists of a simple and objective test that estimates the skeletal muscle function. The Jamar's hydraulic dynamometer will be used, since it is recommended by the American Society of Hand Therapists (ASHT) and is considered the most accurate and precise instrument used to assess HHD .
Fatigue Assessment The questionnaire by Chalder et al. (Annex), which was validated in Brazil will be applied to assess fatigue.
Exercise Tolerance Testing The exercise capacity is assessed by the walking test with progressive loading or Shuttle Walk Test.
Phase 2. Intervention A double-blind, randomized, placebo-controlled study will be performed. After the evaluation of serum vitamin D levels, patients with vitamin D below 30ng/mL will be randomized into two groups. One group will receive supplementation with cholecalciferol (vitamin D3) tablets and the other group will receive placebo. Those will be provided at no cost to the patients. The dosage of 1.500-2.000 IU (International Units) vitamin D/day is recommended in order to meet the need of vitamin D above 30ng/mL in adults. However, a dose at least 2 to 3 times higher is recommended for CD patients due to malabsorption, significant loss of adipose tissue and use of glucocorticoids. Thus, the dose of 50,000IU/week will be administered in a single dose.
The contraindications and precautions on the use of vitamin D will be respected, namely: hypersensitivity to the D-group vitamins, hypercalcemia, hypercalciuria and metastatic calcification; and interactions with digitalis, thiazides, and anticonvulsant and antacid medications.
Despite the possible interference of the skin melanin concentration in vitamin D absorption, no evidence was found to support the differentiated supplementation between Afro descendant and Caucasian individuals.
The patients drawn to the placebo group will receive inert content tablets without therapeutic effect. After the study completion, these control patients will receive complete treatment for hypovitaminosis D.
Throughout the intervention phase, both the treated group and the control group patients will be monitored by phone every 15 days in order to optimize their adhesion.
Phase 3. Reassessment At the end of 6 months of supplementation with cholecalciferol (vitamin D3), this subgroup of patients will be subjected to the same assessments performed in phase 1.
- Conditions
- Crohn Disease, Vitamin D Deficiency, Fatigue, Sarcopenia, Muscle Weakness, Disorder of Bone Density and Structure, Unspecified
- Being tested
- Vitamin D, Placebo
- Keywords
- Crohn Disease, Fatigue, Osteopenia, Exercise Tolerance, Vitamin d
- Medical subject headings
- Crohn Disease, Vitamin D Deficiency, Fatigue, Sarcopenia, Muscle Weakness, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
investigate the relationship between musculoskeletal manifestations, in Crohn population, and the hypovitaminosis D
PlaceboOther
compare the musculoskeletal manifestations of the Placebo group with the group receiving Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Tablets with 50000UI cholecalciferol (vitamin D3) will be administered, weekly, for six months. Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | The patients selected to the placebo group will receive inert content tablets without therapeutic effect, weekly, for six months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the grip strength in patients with Crohn under vitamin D supplementation
Grip strength will be expressed in kg
Measured: After 6 months of supplementation with vitamin D
Secondary outcomes (9)
Increase in mineral bone density (MBD)
MBD assessed by DXA, expressed in gr/cm²
Measured: After 6 months of supplementation with vitamin D
Decrease in fecal Calprotectin levels
Levels of calprotectin under 200µg/g
Measured: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (TNF-α)
TNF-α expressed in pg/ml
Measured: After 6 months of supplementation with vitamin D
Increase in exercise capacity assessed by Shuttle Walk Test (SWT)
Improvement in the distance achieved in the SWT expressed in meters (m)
Measured: After 6 months of supplementation with vitamin D
Increase in lean body mass in patients with Crohn under vitamin D supplementation
Body mass will be assessed by DXA and will be expressed in kg
Measured: After 6 months of supplementation with vitamin D
Reduction in fatigue perception in patients with Crohn under vitamin D supplementation
Fatigue will be measured by the Chalder Fatigue Questionnaire (CFQ). The CFQ is analyzed by 2 domains physical and mental (cutoff: patient's total score higher than 2)
Measured: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (IL 6)
IL 6 expressed in pg/ml
Measured: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (IL 17)
IL 17 expressed in pg/ml
Measured: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (CRP)
CRP expressed in mg/dl
Measured: After 6 months of supplementation with vitamin D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2020 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized, placebo-controlled study will be performed. After the evaluation of serum vitamin D levels, patients with vitamin D below 30ng/mL will be randomized into two groups. One group will receive supplementation with cholecalciferol (vitamin D3) tablets and the other group will receive placebo. Those will be provided at no cost to the patients. The dosage of 1.500-2.000 IU (International Units) vitamin D/day is recommended in order to meet the need of vitamin D above 30ng/mL in adults. However, a dose at least 2 to 3 times higher is recommended for CD patients due to malabsorption, significant loss of adipose tissue and use of glucocorticoids. Thus, the dose of 50,000IU/week will be administered in a single dose. The patients drawn to the placebo group will receive inert content tablets without therapeutic effect. After the study completion, these control patients will receive complete treatment for hypovitaminosis D.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Lorena Nagme de Oliveira Pinto, Federal University of Juiz de Fora
- Investigators
- Júlio MF Chebli, Professor, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704624
- Sponsor's protocol ID
- CAAE41674814500005147
- Status last verified
- Apr 2018
- First submitted
- 24 Feb 2016
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bernstein CN, Seeger LL, Sayre JW, Anton PA, Artinian L, Shanahan F. Decreased bone density in inflammatory bowel disease is related to corticosteroid use and not disease diagnosis. J Bone Miner Res. 1995 Feb;10(2):250-6. doi: 10.1002/jbmr.5650100211.
PubMed 7754804Beck A, Bager P, Jensen PE, Dahlerup JF. How fatigue is experienced and handled by female outpatients with inflammatory bowel disease. Gastroenterol Res Pract. 2013;2013:153818. doi: 10.1155/2013/153818. Epub 2013 Sep 1.
PubMed 24072994Cho HJ, Costa E, Menezes PR, Chalder T, Bhugra D, Wessely S. Cross-cultural validation of the Chalder Fatigue Questionnaire in Brazilian primary care. J Psychosom Res. 2007 Mar;62(3):301-4. doi: 10.1016/j.jpsychores.2006.10.018.
PubMed 17324680Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol. 2005 Jul;289(1):F8-28. doi: 10.1152/ajprenal.00336.2004.
PubMed 15951480Farraye FA, Nimitphong H, Stucchi A, Dendrinos K, Boulanger AB, Vijjeswarapu A, Tanennbaum A, Biancuzzo R, Chen TC, Holick MF. Use of a novel vitamin D bioavailability test demonstrates that vitamin D absorption is decreased in patients with quiescent Crohn's disease. Inflamm Bowel Dis. 2011 Oct;17(10):2116-21. doi: 10.1002/ibd.21595. Epub 2011 Jan 6.
PubMed 21910173Gaburri PD, Chebli JM, de Castro LE, Ferreira JO, Lopes MH, Ribeiro AM, Alves RA, Froede EC, de Oliveira KS, Gaburri AK, Gaburri D, Meirelles GS, de Souza AF. [Epidemiology, clinical features and clinical course of Crohn's disease: a study of 60 cases]. Arq Gastroenterol. 1998 Oct-Dec;35(4):240-6. Portuguese.
PubMed 10347705Hwang C, Ross V, Mahadevan U. Micronutrient deficiencies in inflammatory bowel disease: from A to zinc. Inflamm Bowel Dis. 2012 Oct;18(10):1961-81. doi: 10.1002/ibd.22906. Epub 2012 Apr 5.
PubMed 22488830Iijima H, Shinzaki S, Takehara T. The importance of vitamins D and K for the bone health and immune function in inflammatory bowel disease. Curr Opin Clin Nutr Metab Care. 2012 Nov;15(6):635-40. doi: 10.1097/MCO.0b013e328357f623.
PubMed 22914505Kim YG, Jang BI. The role of colonoscopy in inflammatory bowel disease. Clin Endosc. 2013 Jul;46(4):317-20. doi: 10.5946/ce.2013.46.4.317. Epub 2013 Jul 31.
PubMed 23964327van Langenberg DR, Gibson PR. Factors associated with physical and cognitive fatigue in patients with Crohn's disease: a cross-sectional and longitudinal study. Inflamm Bowel Dis. 2014 Jan;20(1):115-25. doi: 10.1097/01.MIB.0000437614.91258.70.
PubMed 24297056Peyrin-Biroulet L, Fiorino G, Buisson A, Danese S. First-line therapy in adult Crohn's disease: who should receive anti-TNF agents? Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):345-51. doi: 10.1038/nrgastro.2013.31. Epub 2013 Mar 5.
PubMed 23458890Pludowski P, Karczmarewicz E, Bayer M, Carter G, Chlebna-Sokol D, Czech-Kowalska J, Debski R, Decsi T, Dobrzanska A, Franek E, Gluszko P, Grant WB, Holick MF, Yankovskaya L, Konstantynowicz J, Ksiazyk JB, Ksiezopolska-Orlowska K, Lewinski A, Litwin M, Lohner S, Lorenc RS, Lukaszkiewicz J, Marcinowska-Suchowierska E, Milewicz A, Misiorowski W, Nowicki M, Povoroznyuk V, Rozentryt P, Rudenka E, Shoenfeld Y, Socha P, Solnica B, Szalecki M, Talalaj M, Varbiro S, Zmijewski MA. Practical guidelines for the supplementation of vitamin D and the treatment of deficits in Central Europe - recommended vitamin D intakes in the general population and groups at risk of vitamin D deficiency. Endokrynol Pol. 2013;64(4):319-27. doi: 10.5603/ep.2013.0012.
PubMed 24002961Reich KM, Fedorak RN, Madsen K, Kroeker KI. Vitamin D improves inflammatory bowel disease outcomes: basic science and clinical review. World J Gastroenterol. 2014 May 7;20(17):4934-47. doi: 10.3748/wjg.v20.i17.4934.
PubMed 24803805Romkens TE, van Vugt-van Pinxteren MW, Nagengast FM, van Oijen MG, de Jong DJ. High prevalence of fatigue in inflammatory bowel disease: A case control study. J Crohns Colitis. 2011 Aug;5(4):332-7. doi: 10.1016/j.crohns.2011.02.008. Epub 2011 Mar 24.
PubMed 21683303Sipponen T, Nuutinen H, Turunen U, Farkkila M. Endoscopic evaluation of Crohn's disease activity: comparison of the CDEIS and the SES-CD. Inflamm Bowel Dis. 2010 Dec;16(12):2131-6. doi: 10.1002/ibd.21300.
PubMed 20848462
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02704624
- Acronym / sponsor ID
- CAAE41674814500005147
- Conditions
- Crohn Disease, Vitamin D Deficiency, Fatigue, Sarcopenia, Muscle Weakness, Disorder of Bone Density and Structure, Unspecified
- Keywords
- Crohn Disease, Fatigue, Osteopenia, Exercise Tolerance, Vitamin d
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thus, the aim of the current study is to assess the influence of vitamin D deficiency and, consequently, of serum calcium deficiency in the body composition, muscular activity, bone mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to determine the impact of vitamin D supplementation on this population.
Detailed description
This will be a clinical, randomized, controlled, and double-blind trial comprising a consecutive sample of 110 CD patients in remission and low serum vitamin D levels treated by the Gastroenterology team of the Inflammatory Intestinal Disease Clinic at the University Hospital (HU/CAS), Federal University of Juiz de Fora (UFJF). These patients will be divided into two groups with 55 patients each. One group will receive vitamin D supplementation (50.000 UI/week) and the other will receive placebo. Upon the approval by the Ethics Committee of the UFJF, the study aims and procedures will be previously explained to the individuals, who will sign an informed consent form.
The sample size was based on the handgrip strength test, assuming an alpha risk of 5 % and beta risk of 80 %, standard deviation of 2.5, and a difference in magnitude of 30% of response between intervention and placebo group, the sample size needed was 45 patients in each group. Therefore, considering potential losses, 55 patients will be recruited for each group, requiring a total of 110 volunteers.
Study procedure
Phase 1. Assessment All patients in the study will be subjected to the following tests: a. clinical assessment; B. biochemical assessment; c. body composition assessment/anthropometry; d. bone mineral density assessment; e. peripheral muscle strength assessment; f. fatigue assessment; g.Exercise Tolerance Testing
Clinical Assessment of the Disease The following data will be collected in the initial assessment: age, gender, CD duration, data related to the Montreal Classification (age at the time of diagnosis, disease behavior and location), glucocorticoid use and number of exacerbations in the previous year. The inflammatory activity assessment will be held according to the Harvey-Bradshaw Index, When the score is less than 5, the disease is considered to be inactive.
Biochemical Assessment The participants will be instructed to fast 12 hours prior to the blood sampling for analysis. A 5 ml venous blood sample will be collected from the patients in order to determine biochemical parameters. The University Hospital routine laboratory will analyze the venous blood, the levels of C-reactive protein (CRP), calcium, 25-hydroxyvitamin D, parathyroid hormone (PTH) and inflammatory cytokines such as Interleukins (IL) 17, IL 6 and Tumor necrosis factor alfa (TNF-α) . CRP and serum calcium are routinely evaluated in all CD patients under follow-up in the inflammatory bowel disease clinic at HU/CAS.
The following reference values will be taken into consideration regarding 25-hydroxyvitamin D: < 20ng/mL = deficiency, between 21 and 29 ng/mL = insufficiency, and > 30 ng/mL = satisfactory.
Bone Mineral Density Assessment A bone densitometer, Lunar Prodigy Primo (pr + 351035), will be used to measure the patients' bone mineral density (BMD), expressed in g/cm2, by dual-energy x-ray absorptiometry (DXA). The double-energy X-ray densitometry of the skeleton or specific sites such as the spine and the hip is based on the X-rays absorption by the calcium crystals in the bone. The lumbar spine regions between L1 and L4 and those of the total proximal femur will be assessed. The examination will be held under appropriate conditions, according to the technical quality controls. The coefficient of variation for the lumbar spine and total proximal femur will be obtained based on these results. The low BMD will be defined by the reduction greater than -2.0 standard deviations from the reference value mean of healthy individuals, adjusted according to height, age and gender (Z score), in compliance with the official positions of the International Society for Clinical Densitometry (ISCD).
Body Composition Assessment/Anthropometry The assessment will be held through the Quantum BIA (bioelectrical impedance analysis) bioimpedance device. The device is four-pole, has digital display, and provides resistance and reactance values. Total and segmental body composition parameters will be also assessed by DXA expressed in kg.
Muscle Strength Assessment The peripheral muscle strength will be assessed through the maximum voluntary handgrip strength using hand-held dynamometry (HHD), which consists of a simple and objective test that estimates the skeletal muscle function. The Jamar's hydraulic dynamometer will be used, since it is recommended by the American Society of Hand Therapists (ASHT) and is considered the most accurate and precise instrument used to assess HHD .
Fatigue Assessment The questionnaire by Chalder et al. (Annex), which was validated in Brazil will be applied to assess fatigue.
Exercise Tolerance Testing The exercise capacity is assessed by the walking test with progressive loading or Shuttle Walk Test.
Phase 2. Intervention A double-blind, randomized, placebo-controlled study will be performed. After the evaluation of serum vitamin D levels, patients with vitamin D below 30ng/mL will be randomized into two groups. One group will receive supplementation with cholecalciferol (vitamin D3) tablets and the other group will receive placebo. Those will be provided at no cost to the patients. The dosage of 1.500-2.000 IU (International Units) vitamin D/day is recommended in order to meet the need of vitamin D above 30ng/mL in adults. However, a dose at least 2 to 3 times higher is recommended for CD patients due to malabsorption, significant loss of adipose tissue and use of glucocorticoids. Thus, the dose of 50,000IU/week will be administered in a single dose.
The contraindications and precautions on the use of vitamin D will be respected, namely: hypersensitivity to the D-group vitamins, hypercalcemia, hypercalciuria and metastatic calcification; and interactions with digitalis, thiazides, and anticonvulsant and antacid medications.
Despite the possible interference of the skin melanin concentration in vitamin D absorption, no evidence was found to support the differentiated supplementation between Afro descendant and Caucasian individuals.
The patients drawn to the placebo group will receive inert content tablets without therapeutic effect. After the study completion, these control patients will receive complete treatment for hypovitaminosis D.
Throughout the intervention phase, both the treated group and the control group patients will be monitored by phone every 15 days in order to optimize their adhesion.
Phase 3. Reassessment At the end of 6 months of supplementation with cholecalciferol (vitamin D3), this subgroup of patients will be subjected to the same assessments performed in phase 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomized, placebo-controlled study will be performed. After the evaluation of serum vitamin D levels, patients with vitamin D below 30ng/mL will be randomized into two groups. One group will receive supplementation with cholecalciferol (vitamin D3) tablets and the other group will receive placebo. Those will be provided at no cost to the patients. The dosage of 1.500-2.000 IU (International Units) vitamin D/day is recommended in order to meet the need of vitamin D above 30ng/mL in adults. However, a dose at least 2 to 3 times higher is recommended for CD patients due to malabsorption, significant loss of adipose tissue and use of glucocorticoids. Thus, the dose of 50,000IU/week will be administered in a single dose. The patients drawn to the placebo group will receive inert content tablets without therapeutic effect. After the study completion, these control patients will receive complete treatment for hypovitaminosis D.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DTablets with 50000UI cholecalciferol (vitamin D3) will be administered, weekly, for six months. |
| Placebo | Placebo comparator | Other: PlaceboThe patients selected to the placebo group will receive inert content tablets without therapeutic effect, weekly, for six months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Crohn's Disease (moderate to severe)
- Remission of Crohn's activity
- Reduced blood levels of vitamin D
Key exclusion criteria (9 listed)
- Presence of other chronic concomitant disease
- Presence of other autoimmune disease
- Presence of sleep disturbance
- Abuse of alcohol and other drugs
- Pregnancy or lactation, climacteric and/or menopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Dinvestigate the relationship between musculoskeletal manifestations, in Crohn population, and the hypovitaminosis D | Dietary supplement | Vitamin D |
| Placebocompare the musculoskeletal manifestations of the Placebo group with the group receiving Vitamin D | Other | Placebo |
Primary outcome
Increase in the grip strength in patients with Crohn under vitamin D supplementation
Time frame: After 6 months of supplementation with vitamin D
Grip strength will be expressed in kg
9 secondary outcomes
Increase in mineral bone density (MBD)
Time frame: After 6 months of supplementation with vitamin D
Decrease in fecal Calprotectin levels
Time frame: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (TNF-α)
Time frame: After 6 months of supplementation with vitamin D
Increase in exercise capacity assessed by Shuttle Walk Test (SWT)
Time frame: After 6 months of supplementation with vitamin D
Increase in lean body mass in patients with Crohn under vitamin D supplementation
Time frame: After 6 months of supplementation with vitamin D
Reduction in fatigue perception in patients with Crohn under vitamin D supplementation
Time frame: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (IL 6)
Time frame: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (IL 17)
Time frame: After 6 months of supplementation with vitamin D
Global reduction in laboratorial inflammatory biomarkers (CRP)
Time frame: After 6 months of supplementation with vitamin D
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 7754804Bernstein CN, Seeger LL, Sayre JW, Anton PA, Artinian L, Shanahan F. Decreased bone density in inflammatory bowel disease is related to corticosteroid use and not disease diagnosis. J Bone Miner Res. 1995 Feb;10(2):250-6. doi: 10.1002/jbmr.5650100211.
- Background: PubMed 24072994Beck A, Bager P, Jensen PE, Dahlerup JF. How fatigue is experienced and handled by female outpatients with inflammatory bowel disease. Gastroenterol Res Pract. 2013;2013:153818. doi: 10.1155/2013/153818. Epub 2013 Sep 1.
- Background: PubMed 17324680Cho HJ, Costa E, Menezes PR, Chalder T, Bhugra D, Wessely S. Cross-cultural validation of the Chalder Fatigue Questionnaire in Brazilian primary care. J Psychosom Res. 2007 Mar;62(3):301-4. doi: 10.1016/j.jpsychores.2006.10.018.
- Background: PubMed 15951480Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol. 2005 Jul;289(1):F8-28. doi: 10.1152/ajprenal.00336.2004.
- Background: PubMed 21910173Farraye FA, Nimitphong H, Stucchi A, Dendrinos K, Boulanger AB, Vijjeswarapu A, Tanennbaum A, Biancuzzo R, Chen TC, Holick MF. Use of a novel vitamin D bioavailability test demonstrates that vitamin D absorption is decreased in patients with quiescent Crohn's disease. Inflamm Bowel Dis. 2011 Oct;17(10):2116-21. doi: 10.1002/ibd.21595. Epub 2011 Jan 6.
- Background: PubMed 10347705Gaburri PD, Chebli JM, de Castro LE, Ferreira JO, Lopes MH, Ribeiro AM, Alves RA, Froede EC, de Oliveira KS, Gaburri AK, Gaburri D, Meirelles GS, de Souza AF. [Epidemiology, clinical features and clinical course of Crohn's disease: a study of 60 cases]. Arq Gastroenterol. 1998 Oct-Dec;35(4):240-6. Portuguese.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Júlio MF Chebli, Professor principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Crohn Disease and Vitamin D Deficiency, run by Federal University of Juiz de Fora at 1 site in Brazil.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jun 2018. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Increase in the grip strength in patients with Crohn under vitamin D supplementation (time frame: After 6 months of supplementation with vitamin D). 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 NCT02704624, which also lists 16 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 29 Jun 2018.