| CTRI Number |
CTRI/2021/01/030270 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate if vitamin deficiency in celiac disease patients can be treated with gluten free diet alone or added vitamin D supplementation is required. |
|
Scientific Title of Study
|
Role of supplement in celiac disease patients with vitamin D deficiencies: a randomization control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayanta Samanta |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Faculty Office,
Department of Gastroenterology,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayanta Samanta |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Faculty Office,
Department of Gastroenterology,
PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
09855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar |
| Designation |
Research Associate |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Faculty Office,
Department of Gastroenterology,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914377121 |
| Fax |
|
| Email |
sanjay47pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology,
Post Graduate Institute of Medical Education and Research, Chandigarh, India
Sector -12
Chandigarh - 160012
India |
|
|
Primary Sponsor
|
| Name |
Jayanta Samanta |
| Address |
Faculty Office,
Department of Gastroenterology,
PGIMER, Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jayanta Samanta |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Faculty Office,
Department of Gastroenterology, PGIMER, Chandigarh
Sector -12
Chandigarh - 160012
Chandigarh
CHANDIGARH |
9855319529
dj_samanta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gluten free diet and Vitamin D Supplementation |
All diagnosed celiac disease patients with Vit D deficiency will be subjected to a gluten-free diet and Vitamin D supplementation (60,000 U weekly for 8 weeks). Pre and post serum IgAtTg, Vitamin D levels will be done at 1 month and 3 months. Various other biochemical parameters and a DEXA scan will also be done |
| Comparator Agent |
Gluten free diet only |
All diagnosed celiac disease patients with Vit D deficiency will be subjected to a gluten-free diet only. Pre and post serum IgAtTg, Vitamin D levels will be done at 1 month and 3 months. Various other biochemical parameters and a DEXA scan will also be done |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Age ≥ 14 years
2) diagnosed case of celiac disease by IgAtTg levels and duodenal biopsy
3) Serum Vitamin D deficiency |
|
| ExclusionCriteria |
| Details |
1) Patients not confirmed to have celiac disease as per clinical/histological/ serological workup.
2) Patients not having Vitamin D deficiency at the time of diagnosis.
3) Patients of celiac disease already on GFD or on Vitamin D supplementation
4) Pregnant females
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Follow up Vitamin D levels
|
At 1 month and 3 months after Vitamin D supplementation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DEXA scan, iPTH levels and Quality of life assessment |
At 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Celiac disease (CD) is an autoimmune enteropathy predominantly manifesting as a gastrointestinal (GI) tract related disease, triggered by gluten ingestion in the diet. Within the spectrum of its malabsorption syndrome, multiple vitamin deficiencies have been reported in the literature. Vitamin D deficiency gained limelight because of the high incidence of low bone mineral density (BMD) (approximately 50%) reported in earlier literature in patients with CD. Vitamin D deficiency was considered to be one of the main causes of low BMD in such patients. Although the calcitriol form of Vitamin D regulates calcium homeostasis and accounts for the bone mineral dynamics, the majority of the data exists on the detection of the 25 (OH) vitamin D in the sera of the CD patients, present up to a tune of 20.3-59%. Hence the exact implication of the measured vitamin D and the active form in CD is dubious. The correlation between the level of vitamin D and BMD too remains unclear. Data on the effects of vitamin D supplementation in CD patients have also yielded mixed responses, with very few of them actually showing a benefit. Vitamin D might be rather a silent bystander in CD patients, with substantial data to prove that GFD alone can improve BMD levels as well as vitamin D levels in CD patients. This raises the question of the need for supplementation of vitamin D in cases of CD with vitamin D deficiency, which might be advocated otherwise in day-to-day practice as a knee-jerk reaction. No robust data or randomized controlled trial has ever looked into this aspect and hence the current study has been planned. |