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Completed

NCT Number: NCT03504280

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

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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Key information

Conditions

Hypovitaminosis D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

21 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Primary outcomes

  1. serum 25(OH)D

    Time frame: 3 months

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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