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

Primary Purpose

Hypovitaminosis D

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Cholecalciferol

About this trial

This is an interventional treatment trial for Hypovitaminosis D focused on measuring hypovitaminosis D, cholecalciferol, mehadose

Eligibility Criteria

21 Years - 39 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

high dose IM

high dose oral

low dose oral

Arm Description

cholecalciferol 600,000 IU given intramuscularly

cholecalciferol 600,000 IU given orally

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

Outcomes

Primary Outcome Measures

serum 25(OH)D

serum vitamin D level in ng/ml measured by CLIA method

Secondary Outcome Measures

fatigue

visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale

generalized weakness

visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale

bone pain

visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale

muscle cramps

visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale

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

difficulty in climbing stairs

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

visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale

Full Information

NCT ID

NCT03504280

First Posted

April 5, 2018

Last Updated

April 12, 2018

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT03504280

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypovitaminosis D

Keywords

hypovitaminosis D, cholecalciferol, mehadose

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

single center, interventional, open labelled study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high dose IM

Arm Type

Active Comparator

Arm Description

cholecalciferol 600,000 IU given intramuscularly

Arm Title

high dose oral

Arm Type

Active Comparator

Arm Description

cholecalciferol 600,000 IU given orally

Arm Title

low dose oral

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Primary Outcome Measure Information:

Title

serum 25(OH)D

Description

serum vitamin D level in ng/ml measured by CLIA method

Time Frame

3 months

Secondary Outcome Measure Information:

Title

fatigue

Description

visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

Title

generalized weakness

Description

visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

Title

bone pain

Description

visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

Title

muscle cramps

Description

visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

Title

pain in weight bearing joints

Description

visual analog scale of pain in weight bearing joints during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

Title

difficulty in climbing stairs

Description

visual analog scale of difficulty in climbing stairs during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

Title

difficulty in standing from squatting position

Description

visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shweta Nakarmi, resident

Organizational Affiliation

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Md Nazrul Islam, professor

Organizational Affiliation

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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