Therapeutic effects of vitamin D supplementation in Chinese inflammatory bowel disease patients: an prospective, open-label, randomized controlled pilot study

• Register: ChiCTR
• Last refreshed on: 19 June 2017
• Main ID: ChiCTR-IPR-17011688
• Date of registration: 2017-06-18
• Prospective Registration: No
• Primary sponsor: Department of Gastroenterology, Peking Union Medical College Hospital
• Public title: Therapeutic effects of vitamin D supplementation in Chinese inflammatory bowel disease patients: an prospective, open-label, randomized controlled pilot study
• Scientific title: Therapeutic effects of vitamin D supplementation in Chinese inflammatory bowel disease patients: an prospective, open-label, randomized controlled pilot study
• Date of first enrolment: 2010-12-01
• Target sample size: Arm A:25;Arm B:25;Arm C:25;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=19679
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Pilot study

Countries of recruitment

China

Contacts

• Name: Jiaming Qian
• Affiliation: Department of Gastroenterology, Peking Union Medical College Hospital

• Name: BEI TAN
• Affiliation: Department of Gastroenterology, Peking Union Medical College Hospital

Key inclusion & exclusion criteria

Inclusion criteria: We prospectively enrolled inflammatory bowel disease (IBD) patients who visited our IBD clinic or were admitted to the Department of Gastroenterology of Peking Union Medical College Hospital. All patients diagnosed with IBD according to Consensus on diagnosis and treatment standard of IBD in China were eligible for enrollment
Exclusion criteria: age<18 years; patients with concurrent endocrine or metabolic diseases leading to secondary osteoporosis, such as primary hyperparathyroidism, severe liver and kidney dysfunction; type 1 diabetes or poorly controlled type 2 diabetes; hypogonadism; hyperthyroidism; connective tissue disease; malignant bone tumor; tumor-associated bone metastasis; multiple myeloma; patients with previous history of fracture or the treatment of osteoporosis; and patients with severe malnutrition or malabsorption.

Age minimum: 18
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory bowel disease

Intervention(s)

Arm A:orally VitD3 150000IU per 3 months plus Ca 600mg daily;Arm B:orally Ca 600mg daily only;Arm C:vehicle control group;

Primary Outcome(s)

25OHD;

Secondary Outcome(s)

Bone mineral density;Ulcerative colitis disease activity;Crohn‘s disease activity’;

Source(s) of Monetary Support

Chinese National Scientific Research Special-Purpose Project in Public Health Profession funds (No.201002020); Chinese Ministry of Education Doctoral Funds (No.20111106110009)