Hypovitaminosis D
Conditions
Keywords
hypovitaminosis D, cholecalciferol, mehadose
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.
Interventions
DRUGCholecalciferol
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single center, interventional, open labelled study
Eligibility
Sex/Gender
ALL
Age
21 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum 25(OH)D | 3 months | serum vitamin D level in ng/ml measured by CLIA method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| fatigue | 3 months | visual analog scale of fatigue 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 |
| 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 |
Outcome results
None listed