An interventional study of Vitamin D3 and placebo in Vitamin D Deficiency, sponsored by Winthrop University Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Winthrop University Hospital · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 228 studies testing cholecalciferol in Vitamin D Deficiency — 9 open to participants now, 16 under way, 2 of them phase 3. Cholecalciferol · Vitamin D Deficiency.
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, this one is the 196th largest by enrollment, is one of 10 that started in 2008, is one of 113 with no phase, and was the 29th registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
Browse Vitamin D Deficiency studies →9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Recruiting first, the newest first:
Aziz Bhatti Shaheed Teaching Hospital · Sites in Pakistan
Ages 6–14
Bangladesh Medical University · Sites in Bangladesh
Ages 20–40 · Men only
National Taiwan University Hospital · Sites in Taiwan
Ages 18+
Peking University First Hospital · Sites in China
Ages 19+
Coordinación de Investigación en Salud, Mexico · Sites in Mexico
Ages 5–17
By country, each count listing its studies:
Cholecalciferol: first FDA approval 2000 (INFUVITE ADULT), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →
Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
228 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 40 · Phase 3 38 · Phase 4 34
First in 2004; this study’s year is marked. 10 started in 2008.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 27 is below the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Median enrollment 72 across the 228 interventional studies. Of the 179 that completed or were terminated, 44 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 228 have an industry lead sponsor. The 10 most frequent:
Winthrop University Hospital is the lead sponsor of 42 studies on the registry; none are open to participants now.
Winthrop University Hospital has 4 studies filed under Vitamin D Deficiency — fewer than ten, so there is no comparison to draw.
6 of the studies testing cholecalciferol in Vitamin D Deficiency that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03188796Phase 3Medical University of GrazThe VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients | 2027-07 |
| NCT04677816Wake Forest University Health SciencesImpact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients | 2026-12 |
| NCT03613116University of California, DavisHigh-dose Vitamin D Supplements in Older Adults | 2026-12-31 |
| NCT07914478Aziz Bhatti Shaheed Teaching HospitalRole of Vitamin D Supplementation in Children With Irritable Bowel Syndrome | 2027-03-30 |
| NCT07006714University of MiamiPreoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) | 2027-07-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. This study also looks at changes in vitamin D level in obese patients undergoing medical weight loss. It is thought that obese patients have vitamin D deficiency through storage of vitamin D in the fat compartment not readily available for blood measurement. The investigators' hypothesis is that with medical weight loss vitamin D levels will increase in obese subjects.
We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.
To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of subjects will be randomized to the placebo group.
Drug: placebo
This is the study group that receives Vitamin D supplementation.
Drug: Vitamin D3
Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.
The placebo group will receive sugar pills appearing similar to the vitamin D capsules.
Mean Level of 25(OH)D
Vitamin D (25(OH)D) level at Baseline.
Time frame: Baseline
Mean Level of 25(OH)D
Vitamin D (25(OH)D) level at Month 2.
Time frame: Week 8
Volunteers were recruited during the winter months from areas in a surrounding Long Island, New York by advertisement through flyers and direct mail. Volunteers were 18-65 years old with a BMI of \>35kg/m2. Recruitment began in January of 2009 at the Bone Mineral Research Center at Winthrop University Hospital
| Milestone | Placebo | Vitamin D3 |
|---|---|---|
| Started | 13 | 14 |
| Completed | 13 | 14 |
| Not completed | 0 | 0 |
Vitamin D (25(OH)D) level at Baseline.
| nmol/L | Placebo | Vitamin D |
|---|---|---|
| Mean Level of 25(OH)D | 51.1 ± 13.9 | 49.2 ± 15.3 |
Vitamin D (25(OH)D) level at Month 2.
| nmol/L | Placebo | Vitamin D |
|---|---|---|
| Mean Level of 25(OH)D | 49.9 ± 17.9 | 74.5 ± 13.43 |
Collected over Adverse events were collected from the date the patient started the study medications until the date they completed the study, typically 2 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/13 (0%) | 0/13 (0%) |
| Vitamin D3 | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Placebo | Vitamin D3 | Total |
|---|---|---|---|
| Mean | 55.8 ± 7.43 | 53.5 ± 12.5 | 54.8 ± 9.83 |
| Age, Customized(participants) | Placebo | Vitamin D3 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 14 | 27 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(participants) | Placebo | Vitamin D3 | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 8 | 6 | 14 |
| Region of Enrollment(participants) | Placebo | Vitamin D3 | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Dec 2008, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2023, 9 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cholecalciferol
Winthrop University Hospital