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

Hypovitaminosis D Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504280
• Other study ID #: VitaminD
• Status: Completed
• Phase: N/A
• First received: April 5, 2018
• Last updated: April 12, 2018
• Start date: April 2015
• Est. completion date: October 2017

Study information

• Verified date: April 2018
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25(OH)D	serum vitamin D level in ng/ml measured by CLIA method	3 months
Secondary	fatigue	visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale	3 months
Secondary	generalized weakness	visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale	3 months
Secondary	bone pain	visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale	3 months
Secondary	muscle cramps	visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale	3 months
Secondary	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
Secondary	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
Secondary	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