ObesityPhase 4NCT02435771
Efficacy Of Ergocalciferol In Adults According To BMI
A Phase 4 study testing Ergocalciferols in people with Obesity and Vitamin D Deficiency, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Vitamin D Deficiency
- What is being tested?
- Ergocalciferols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2017
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study subjects have to be between the ages of 18 to 65 with a serum 25OHD level less than 20 ng/ml.
Who cannot join
- Participants will be excluded if they have any of the following:
- Due to the inaccuracies of BMI in patients with increased muscle mass, in group with a BMI 25-35: men with a waist circumference < 90 cm ; women < 80 cm
- Chronic liver disease defined by any clinical or a history of serum AST or ALT > 2 times ULN
- Kidney disease defined as a GFR <60 ml/min
- Sarcoidosis
- Any known malignancy
Show all 17Show fewer
- Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
- Primary hyperparathyroidism or hypercalcemia,
- Patients that are pregnant or considering pregnancy.
- Patients taking certain medications such as glucocorticoids, anti-seizure medications such has phenobarbital or phenytoin or patients taking antiviral medications for HIV as these are known to cause vitamin D deficiency
- Individuals excluded from having a DXA scan
- Study participants will be excluded from having a DXA scan if any of the following:
- Any amputation of a extremity including toes
- If they have a pacemaker, automatic defibrillator, coronary stents or metal suture material in the heart
- If they have artificial joints, pins, plate or any other type of metal objects
- If they have received contrast material such as barium in the past 7 days
- If they have had a nuclear medicine study in the past 3 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Vitamin D deficiency is associated with several adverse outcomes such as increased fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The increasing prevalence of vitamin D deficiency has been attributed to the increasing prevalence of obesity. Several studies have shown that obese patients have lower 25-OH vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more vitamin D compared to nonobese patients. The most commonly prescribed medication to replete vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been published to evaluate a standard protocol in the treatment of vitamin D insufficiency in adults.
- Conditions
- Obesity, Vitamin D Deficiency
- Being tested
- Ergocalciferols
- Medical subject headings
- Obesity, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolsDrug
Treatment 1- 400,000 IU
ErgocalciferolsDrug
Treatment 2- 800,000 IU
| Study group | Role | What they receive |
|---|---|---|
| BMI <25 | Experimental | Normal BMI Receives: Drug: Ergocalciferols |
| BMI 25-35 | Experimental | Overweight and obese by BMI Receives: Drug: Ergocalciferols |
| BMI >35 | Experimental | Obese by BMI Receives: Drug: Ergocalciferols |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxy-vitamin D level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJul 2011
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: failed to meet enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alicia L Warnock, MD, Principal investigator, WRNMMC-BPatrick W Clyde, MD, Study director, WRNMMC-BVinh Mai, MD, Study chair, WRNMMC-BVerna Parchment, Study chair, WRNMMC-B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435771
- Sponsor's protocol ID
- 359128-8
- Status last verified
- May 2017
- First submitted
- 21 May 2013
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Ergocalciferol In Adults According To BMI
- ClinicalTrials.gov ID
- NCT02435771
- Acronym / sponsor ID
- 359128-8
- Conditions
- Obesity, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failed to meet enrollment goals
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Jul 2011
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 6 May 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.
Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Vitamin D deficiency is associated with several adverse outcomes such as increased fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The increasing prevalence of vitamin D deficiency has been attributed to the increasing prevalence of obesity. Several studies have shown that obese patients have lower 25-OH vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more vitamin D compared to nonobese patients. The most commonly prescribed medication to replete vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been published to evaluate a standard protocol in the treatment of vitamin D insufficiency in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI <25 | Experimental | Drug: ErgocalciferolsNormal BMI |
| BMI 25-35 | Experimental | Drug: ErgocalciferolsOverweight and obese by BMI |
| BMI >35 | Experimental | Drug: ErgocalciferolsObese by BMI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study subjects have to be between the ages of 18 to 65 with a serum 25OHD level less than 20 ng/ml.
Key exclusion criteria (17 listed)
- Participants will be excluded if they have any of the following:
- Any amputation of a extremity including toes
- If they have a pacemaker, automatic defibrillator, coronary stents or metal suture material in the heart
- If they have artificial joints, pins, plate or any other type of metal objects
- If they have received contrast material such as barium in the past 7 days
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 |
|---|---|---|
| ErgocalciferolsTreatment 1- 400,000 IU | Drug | BMI 25-35, BMI <25, BMI >35 |
| ErgocalciferolsTreatment 2- 800,000 IU | Drug | BMI 25-35, BMI <25, BMI >35 |
Primary outcome
serum 25-hydroxy-vitamin D level
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: failed to meet enrollment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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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.
Alicia L Warnock, MD principal investigator
WRNMMC-B
Patrick W Clyde, MD study director
WRNMMC-B
Vinh Mai, MD study chair
WRNMMC-B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferols in people with Obesity and Vitamin D Deficiency, run by Walter Reed National Military Medical Center at 1 site in United States.
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 17 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: stopped early, as of the sponsor's last update on 11 May 2017. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: failed to meet enrollment goals). Results are not available in the source record.
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-hydroxy-vitamin D level (time frame: 12 weeks). 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 11 May 2017.