Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
Primary Purpose
Hypovitaminosis D
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Hypovitaminosis D focused on measuring hypovitaminosis D, cholecalciferol, mehadose
Eligibility Criteria
Inclusion Criteria:
- hypovitaminosis D (serum 25 OH D < 20 ng/ml)
Exclusion Criteria:
- Chronic disease causing Vitamin D deficiency like CKD, nephrotic syndrome, liver disease, hyperparathyroidism, history of skin graft, malabsorption, hyperthyroidism, drugs like anticonvulsants, glucocorticoids, HAART Current pregnancy Lactose intolerance Previously treated with bolus Vitamin D supplementation within previous three months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
high dose IM
high dose oral
low dose oral
Arm Description
cholecalciferol 600,000 IU given intramuscularly
cholecalciferol 600,000 IU given orally
cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU
Outcomes
Primary Outcome Measures
serum 25(OH)D
serum vitamin D level in ng/ml measured by CLIA method
Secondary Outcome Measures
fatigue
visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale
generalized weakness
visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale
bone pain
visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale
muscle cramps
visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale
pain in weight bearing joints
visual analog scale of pain in weight bearing joints during last 7 days of interview measured in 10 cm scale
difficulty in climbing stairs
visual analog scale of difficulty in climbing stairs during last 7 days of interview measured in 10 cm scale
difficulty in standing from squatting position
visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale
Full Information
NCT ID
NCT03504280
First Posted
April 5, 2018
Last Updated
April 12, 2018
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT03504280
Brief Title
Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
Official Title
Changes in Serum Vitamin D Level and Clinical Parameters After Different Loading Doses of Cholecalciferol (D3) in Young Adults With Vitamin D Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
it is a clinical trial to observe increase in serum vitamin D level and clinical symptoms after 3 different doses of cholecalciferol given either intramuscularly or oral.
Detailed Description
A prospective, interventional study was conducted in Department of Rheumatology, BSMMU, Dhaka, Bangladesh from October 2015 to January 2017. One hundred and five clinically healthy adults of age 21-39 with serum vitamin D concentration were enrolled in the study. Serum vitamin D level was estimated by chemiluminescent micro particle immunoassay method at baseline and 3 months after the intervention. The participants were divided into three groups using random number table. Group A was given 6 lakh IU of cholecalciferol IM stat dose, group B was given 6 lakh IU of cholecalciferol orally with a glass of milk stat dose and group c was given 2 lakh IU of cholecalciferol orally once a month for 2 months followed by tablet cholecalciferol 1000 IU daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
Keywords
hypovitaminosis D, cholecalciferol, mehadose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single center, interventional, open labelled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high dose IM
Arm Type
Active Comparator
Arm Description
cholecalciferol 600,000 IU given intramuscularly
Arm Title
high dose oral
Arm Type
Active Comparator
Arm Description
cholecalciferol 600,000 IU given orally
Arm Title
low dose oral
Arm Type
Active Comparator
Arm Description
cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Primary Outcome Measure Information:
Title
serum 25(OH)D
Description
serum vitamin D level in ng/ml measured by CLIA method
Time Frame
3 months
Secondary Outcome Measure Information:
Title
fatigue
Description
visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
Title
generalized weakness
Description
visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
Title
bone pain
Description
visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
Title
muscle cramps
Description
visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
Title
pain in weight bearing joints
Description
visual analog scale of pain in weight bearing joints during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
Title
difficulty in climbing stairs
Description
visual analog scale of difficulty in climbing stairs during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
Title
difficulty in standing from squatting position
Description
visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
hypovitaminosis D (serum 25 OH D < 20 ng/ml)
Exclusion Criteria:
Chronic disease causing Vitamin D deficiency like CKD, nephrotic syndrome, liver disease, hyperparathyroidism, history of skin graft, malabsorption, hyperthyroidism, drugs like anticonvulsants, glucocorticoids, HAART Current pregnancy Lactose intolerance Previously treated with bolus Vitamin D supplementation within previous three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shweta Nakarmi, resident
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Md Nazrul Islam, professor
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
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