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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose IM | Active Comparator | cholecalciferol 600,000 IU given intramuscularly |
|
| high dose oral | Active Comparator | cholecalciferol 600,000 IU given orally |
|
| low dose oral | Active Comparator | cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum 25(OH)D | serum vitamin D level in ng/ml measured by CLIA method | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| fatigue | visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale | 3 months |
| generalized weakness | visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shweta Nakarmi, resident | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Principal Investigator |
| Md Nazrul Islam, professor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Study Director |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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single center, interventional, open labelled study
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| 3 months |
| bone pain | visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale | 3 months |
| muscle cramps | visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale | 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 | 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 | 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 | 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |