Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
1 other identifier
interventional
105
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedApril 20, 2018
April 1, 2018
2.3 years
April 5, 2018
April 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum 25(OH)D
serum vitamin D level in ng/ml measured by CLIA method
3 months
Secondary Outcomes (7)
fatigue
3 months
generalized weakness
3 months
bone pain
3 months
muscle cramps
3 months
pain in weight bearing joints
3 months
- +2 more secondary outcomes
Study Arms (3)
high dose IM
ACTIVE COMPARATORcholecalciferol 600,000 IU given intramuscularly
high dose oral
ACTIVE COMPARATORcholecalciferol 600,000 IU given orally
low dose oral
ACTIVE COMPARATORcholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU
Interventions
Eligibility Criteria
You may qualify if:
- hypovitaminosis D (serum 25 OH D \< 20 ng/ml)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shweta Nakarmi, resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- STUDY DIRECTOR
Md Nazrul Islam, professor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 20, 2018
Study Start
April 1, 2015
Primary Completion
August 1, 2017
Study Completion
October 1, 2017
Last Updated
April 20, 2018
Record last verified: 2018-04