Hypovitaminosis DNCT03504280
Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
A study testing Cholecalciferol in people with Hypovitaminosis D, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 21 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- hypovitaminosis D (serum 25 OH D < 20 ng/ml)
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Hypovitaminosis D
- Being tested
- Cholecalciferol
- Keywords
- hypovitaminosis D, cholecalciferol, mehadose
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
| Study group | Role | What they receive |
|---|---|---|
| high dose IM | Active comparator | cholecalciferol 600,000 IU given intramuscularly Receives: Drug: Cholecalciferol |
| high dose oral | Active comparator | cholecalciferol 600,000 IU given orally Receives: Drug: Cholecalciferol |
| low dose oral | Active comparator | cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25(OH)D
serum vitamin D level in ng/ml measured by CLIA method
Measured: 3 months
Secondary outcomes (7)
fatigue
visual analog scale of fatigue during last 7 days of interview measured in 10 cm scale
Measured: 3 months
generalized weakness
visual analog scale of generalized weakness during last 7 days of interview measured in 10 cm scale
Measured: 3 months
bone pain
visual analog scale of bone pain during last 7 days of interview measured in 10 cm scale
Measured: 3 months
muscle cramps
visual analog scale of muscle cramps during last 7 days of interview measured in 10 cm scale
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study startApr 2015
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single center, interventional, open labelled study
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shweta Nakarmi, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Shweta Nakarmi, resident, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshMd Nazrul Islam, professor, Study director, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504280
- Sponsor's protocol ID
- VitaminD
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03504280
- Acronym / sponsor ID
- VitaminD
- Conditions
- Hypovitaminosis D
- Keywords
- hypovitaminosis D, cholecalciferol, mehadose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- single center, interventional, open labelled study
| Arm | Type | Receives |
|---|---|---|
| high dose IM | Active comparator | Drug: Cholecalciferolcholecalciferol 600,000 IU given intramuscularly |
| high dose oral | Active comparator | Drug: Cholecalciferolcholecalciferol 600,000 IU given orally |
| low dose oral | Active comparator | Drug: Cholecalciferolcholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- hypovitaminosis D (serum 25 OH D < 20 ng/ml)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol | Drug | high dose IM, high dose oral, low dose oral |
Primary outcome
serum 25(OH)D
Time frame: 3 months
serum vitamin D level in ng/ml measured by CLIA method
7 secondary outcomes
fatigue
Time frame: 3 months
generalized weakness
Time frame: 3 months
bone pain
Time frame: 3 months
muscle cramps
Time frame: 3 months
pain in weight bearing joints
Time frame: 3 months
difficulty in climbing stairs
Time frame: 3 months
difficulty in standing from squatting position
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shweta Nakarmi, resident principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Md Nazrul Islam, professor study director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Hypovitaminosis D, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25(OH)D (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.