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

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ClinicalTrials.gov Identifier: NCT03504280
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Shweta Nakarmi, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Drug: Cholecalciferol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single center, interventional, open labelled study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017


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



Primary Outcome Measures :
  1. serum 25(OH)D [ Time Frame: 3 months ]
    serum vitamin D level in ng/ml measured by CLIA method


Secondary Outcome Measures :
  1. fatigue [ Time Frame: 3 months ]
    visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale

  2. generalized weakness [ Time Frame: 3 months ]
    visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale

  3. bone pain [ Time Frame: 3 months ]
    visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale

  4. muscle cramps [ Time Frame: 3 months ]
    visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale

  5. pain in weight bearing joints [ Time Frame: 3 months ]
    visual analog scale of pain in weight bearing joints during last 7 days of interview measured in 10 cm scale

  6. difficulty in climbing stairs [ Time Frame: 3 months ]
    visual analog scale of difficulty in climbing stairs during last 7 days of interview measured in 10 cm scale

  7. difficulty in standing from squatting position [ Time Frame: 3 months ]
    visual analog scale of difficulty in standing from squatting position during last 7 days of interview measured in 10 cm scale



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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504280


Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Principal Investigator: Shweta Nakarmi, resident BSMMU
Study Director: Md Nazrul Islam, professor BSMMU

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Responsible Party: Dr Shweta Nakarmi, Principle Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03504280     History of Changes
Other Study ID Numbers: VitaminD
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Dr Shweta Nakarmi, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
hypovitaminosis D
cholecalciferol
mehadose

Additional relevant MeSH terms:
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Avitaminosis
Rickets
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents