Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol

Not Applicable

Completed

• Conditions: Hypovitaminosis D
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT03504280
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-12
• Last Update Submitted: 2018-04-12
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose oral	Cholecalciferol	cholecalciferol 600,000 IU given orally
high dose IM	Cholecalciferol	cholecalciferol 600,000 IU given intramuscularly
low dose oral	Cholecalciferol	cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU

Primary Outcome Measures

Name	Time	Method
serum 25(OH)D	3 months	serum vitamin D level in ng/ml measured by CLIA method

Secondary Outcome Measures

Name	Time	Method
fatigue	3 months	visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale
generalized weakness	3 months	visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale
bone pain	3 months	visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale
muscle cramps	3 months	visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale
pain in weight bearing joints	3 months	visual analog scale of pain in weight bearing joints during last 7 days of interview measured in 10 cm scale
difficulty in climbing stairs	3 months	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	3 months	visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale