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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Changes in Serum Vitamin D Level and Clinical Parameters After Different Loading Doses of Cholecalciferol (D3) in Young Adults With Vitamin D Deficiency

Conditions
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Hypovitaminosis D

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single center, interventional, open labelled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high dose IM<br>cholecalciferol 600,000 IU given intramuscularly | Drug: Cholecalciferol<br> <br> |
| Active Comparator: high dose oral<br>cholecalciferol 600,000 IU given orally | Drug: Cholecalciferol<br> <br> |
| Active Comparator: low dose oral<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25(OH)D | serum vitamin D level in ng/ml measured by CLIA method | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypovitaminosis D, cholecalciferol, mehadose