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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Hypovitaminosis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single center, interventional, open labelled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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high dose IM

cholecalciferol 600,000 IU given intramuscularly

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

high dose oral

cholecalciferol 600,000 IU given orally

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

low dose oral

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes