An interventional study of Cholecalciferol in Hypovitaminosis D, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed. Open to participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
cholecalciferol 600,000 IU given intramuscularly
Drug: Cholecalciferol
cholecalciferol 600,000 IU given orally
Drug: 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
Drug: Cholecalciferol
serum 25(OH)D
serum vitamin D level in ng/ml measured by CLIA method
Time frame: 3 months
fatigue
visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale
Time frame: 3 months
generalized weakness
visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale
Time frame: 3 months
bone pain
visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale
Time frame: 3 months
muscle cramps
visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale
Time frame: 3 months
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
Time frame: 3 months
difficulty in climbing stairs
visual analog scale of difficulty in climbing stairs during last 7 days of interview measured in 10 cm scale
Time frame: 3 months
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
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh