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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypovitaminosis D
• Intervention / Treatment: Drug: Cholecalciferol

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: high dose IM; cholecalciferol 600,000 IU given intramuscularly	Drug: Cholecalciferol
Active Comparator: high dose oral; cholecalciferol 600,000 IU given orally	Drug: Cholecalciferol
Active Comparator: 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	Drug: Cholecalciferol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Shweta Nakarmi, resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; Study Director: Md Nazrul Islam, professor, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: cholecalciferol; hypovitaminosis D; mehadose
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Rickets; Avitaminosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: VitaminD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No