Vitamin D DeficiencyPhase 3NCT02594579
Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient
A Phase 3 study testing Vitamin D3 in people with Vitamin D Deficiency and Sarcopenia, run by Mahidol University at 1 site in Thailand.
Trial summary
A randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3 supplementation, compare to placebo, on skeletal muscle mass and body composition. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitamin D Deficiency, Sarcopenia, Critical Illness
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2015to Dec 2016
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years old
- Expected ICU stay ≥ 48 hrs
Who cannot join
- Participate in other clinical trial
- Contraindication to receive oral or enteral feeding
- Do not resuscitate /imminent death
- Vegetative state, generalize weakness, denervation of leg, both leg amputation
- Hypercalcemia or Hypercalcemia at risk
- Hyperphosphatemia,
Show all 10Show fewer
- History of nephrolithiasis
- End stage renal disease on renal replacement therapy
- Pregnancy/lactation
- Consent refusal
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of medicine, Ramathibodi Hospital
Bangkok, 10400
Daruneewan Warodomwichit
Daruneewan Warodomwichit, MD
About this study
Official title: Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency
A randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3 supplementation, compare to placebo, on skeletal muscle mass and body composition.
Read the detailed description
There is a high prevalence of vitamin D deficiency in critically ill patient which is associated with muscle wasting and physical disability. Recent study showed that treatment of vitamin D deficiency with high dose vitamin D improved muscle wasting and may prevent further muscle breakdown.
Investigator want to explore whether a high dose vitamin D3 supplementation, compare to placebo will be able to improve muscle wasting in critically ill patients.
The eligible participant will be asked to sign and date the informed consent document then they will be randomized to receive vitamin D3 supplement or placebo, using the computer generated code in conceal envelope.
Vitamin D3 or placebo will be given orally or feeding tube via feeding tube at a dose of 100,000 IU on day 1 and 3 then 50,000 IU on day 5,7,9,12 followed by 150,000 unit per week for 4 week.
Serum 25-Hydroxyvitamin D, 1,25-dihydroxyvitamin D will be measured at baseline (day 0) then day 10 and day 43 after vitamin D supplementation. Moreover, Investigator will assess the diameter of rectus femoris by using ultrasonography on day 0,10 and 43.
- Conditions
- Vitamin D Deficiency, Sarcopenia, Critical Illness
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Vitamin D Deficiency, Sarcopenia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol (D3-50)
Vitamin D3 100,000 u per day on day 1,3 then 50,000 u/day on day 5,7,9,12 and continue 50,000 u 3 times/ week for 4 weeks
PlaceboDrug
Also called Cholecalciferol (D3-50) placebo
Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin D3 Receives: Drug: Vitamin D3 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus femoris cross-sectional diameer
A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo
Measured: Change from baseline Rectus femoris cross-sectional diameter at day 43
Secondary outcomes (4)
Length of hospital stays
Participant will be followed for the duration of hospital stay
Measured: An expected average of 3 weeks
Length of ICU stays
Participant will be followed for the duration of ICU stay
Measured: An expected average of 2 weeks
Percentage of skeletal muscle mass
Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis
Measured: Change from basline percentage skeletal muscle mass at day 43
Correction vitamin D deficiency
Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daruneewan Warodomwichit, Principal investigator, Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594579
- Sponsor's protocol ID
- 075802
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT02594579
- Acronym / sponsor ID
- 075802
- Conditions
- Vitamin D Deficiency, Sarcopenia, Critical Illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- 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.
A randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3 supplementation, compare to placebo, on skeletal muscle mass and body composition.
Detailed description
There is a high prevalence of vitamin D deficiency in critically ill patient which is associated with muscle wasting and physical disability. Recent study showed that treatment of vitamin D deficiency with high dose vitamin D improved muscle wasting and may prevent further muscle breakdown.
Investigator want to explore whether a high dose vitamin D3 supplementation, compare to placebo will be able to improve muscle wasting in critically ill patients.
The eligible participant will be asked to sign and date the informed consent document then they will be randomized to receive vitamin D3 supplement or placebo, using the computer generated code in conceal envelope.
Vitamin D3 or placebo will be given orally or feeding tube via feeding tube at a dose of 100,000 IU on day 1 and 3 then 50,000 IU on day 5,7,9,12 followed by 150,000 unit per week for 4 week.
Serum 25-Hydroxyvitamin D, 1,25-dihydroxyvitamin D will be measured at baseline (day 0) then day 10 and day 43 after vitamin D supplementation. Moreover, Investigator will assess the diameter of rectus femoris by using ultrasonography on day 0,10 and 43.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin D3Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Drug: PlaceboDietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 70 years old
- Expected ICU stay ≥ 48 hrs
Key exclusion criteria (10 listed)
- Participate in other clinical trial
- Contraindication to receive oral or enteral feeding
- Do not resuscitate /imminent death
- Vegetative state, generalize weakness, denervation of leg, both leg amputation
- Hypercalcemia or Hypercalcemia at risk
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 |
|---|---|---|
| Vitamin D3Also: Cholecalciferol (D3-50)Vitamin D3 100,000 u per day on day 1,3 then 50,000 u/day on day 5,7,9,12 and continue 50,000 u 3 times/ week for 4 weeks | Drug | Vitamin D |
| PlaceboAlso: Cholecalciferol (D3-50) placeboPlacebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks | Drug | Placebo |
Primary outcome
Rectus femoris cross-sectional diameer
Time frame: Change from baseline Rectus femoris cross-sectional diameter at day 43
A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo
4 secondary outcomes
Length of hospital stays
Time frame: An expected average of 3 weeks
Length of ICU stays
Time frame: An expected average of 2 weeks
Percentage of skeletal muscle mass
Time frame: Change from basline percentage skeletal muscle mass at day 43
Correction vitamin D deficiency
Time frame: 43 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Daruneewan Warodomwichit principal investigator
Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 in people with Vitamin D Deficiency and Sarcopenia, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daruneewan Warodomwichit ((662)2011000 ext. 0082, daruneewan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectus femoris cross-sectional diameer (time frame: Change from baseline Rectus femoris cross-sectional diameter at day 43). 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 3 Nov 2015.