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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status: Completed

Conditions: Hypovitaminosis D

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT03504280

VitaminD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 21 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

high dose IM

Active Comparator group

Description:

cholecalciferol 600,000 IU given intramuscularly

Treatment:

Drug: Cholecalciferol

high dose oral

Active Comparator group

Description:

cholecalciferol 600,000 IU given orally

Treatment:

Drug: Cholecalciferol

low dose oral

Active Comparator group

Description:

cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU

Treatment:

Drug: Cholecalciferol