Colorectal PolypsPhase 1NCT00298545
Effect of Vitamin D and Calcium on Genes in the Colon
A Phase 1 study testing Calcium and Calcitriol in people with Colorectal Polyps and Colorectal Adenoma, run by Rockefeller University at 1 site in United States.
Trial summary
The researchers are involved in a research program to understand how vitamin D and calcium in the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end, the researchers are conducting a study of vitamin D supplementation in which volunteer subjects are provided a Western style diet for… Read more about this study
- Who is it for?
- Ages 48 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps, Colorectal Adenoma, Adenocarcinoma
- What is being tested?
- Calcium and Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to May 2009
- Phase
- Phase 1
- 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 48 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers with a history of pre-cancerous colorectal polyps and/or have a family history of pre-cancerous polyps or colon cancer
- Not taking any medications known to affect either calcium metabolism or colon function
- Between the ages of 48 and 72 years old
- Have had pre-cancerous colorectal polyps or have first or second degree relatives with colorectal cancer and are therefore at increased risk for the disease
Who cannot join
- Personal history of cancer other than non-melanoma skin cancer
- Diseases of the bowel such as intestinal malabsorption or inflammatory bowel disease
- Prior gastrointestinal surgery including gastrectomy, small or large bowel resections. (If one has had an appendectomy or surgery of the esophagus, he/she is still eligible.)
- Any excessive bleeding or clotting disorders
- Taking blood thinners
- Abnormalities of or conditions predisposing one to abnormalities of calcium metabolism. (This includes untreated hyperparathyroidism [increase in parathyroid function] and history of milk-alkali syndrome, a type of calcium metabolism disease.)
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- Untreated hyperthyroidism (increase in thyroid function)
- Regularly take greater than 660 mg of aspirin per day. This is greater than two tablets of 325 mg regular strength aspirin or greater than one tablet of 500 mg of extra strength aspirin per day. (If one has been taking aspirin for heart or blood vessel protection regularly for at least one month before his/her first screening visit, he/she will remain on the same amount of medicine throughout the study. The following amounts are acceptable:
- Aspirin 1 to 2 regular tablets (325 mg) per day, or
- Baby aspirin 1 tablet (81 mg) per day
- Regularly take daily dosages of nonsteroidal anti-inflammatory agents (NSAIDs) within the last 3 months. (One example of an NSAID is ibuprofen.)
- Taking greater than 1200 mg of dietary calcium daily
- Taking medications called sterol-binding resins, such as cholestyramine (Questran®), which is for the treatment of high blood cholesterol
- Taking other investigational drugs or multiple other medications that might, in the opinion of the investigator, affect the study measurements.
- Other serious illness(es) that are anticipated to limit life expectancy to less than 6 months
- Elevated blood pressure greater than 160/100 mmHg
- HIV positive
- Pregnant or nursing
- A history of kidney stones
- Liver disease and/or kidney disease
- Diabetes mellitus
- High "bad" cholesterol level, low density lipoprotein (LDL) greater than 175 mg/dl or triglyceride levels greater than 600 mg/dl
- Known history of coronary artery disease
- EKG (electrocardiogram is a record of the electrical activity of the heart) changes consistent with a past heart attack (myocardial infraction)
- Currently taking:
- Antidiabetic medication
- Hormone replacement therapies, oral, injected or implanted contraceptives. (Thyroid hormone replacement is allowed as long as one's thyroid test is normal.)
- Vitamin, mineral, fish oil, and herbal supplementation and weight control medication must be stopped at least 1 month prior to enrolling in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: High vs. Low Calcium Intake in the Presence of High Vitamin D: Effect on Gene Expression in the Colon
The researchers are involved in a research program to understand how vitamin D and calcium in the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end, the researchers are conducting a study of vitamin D supplementation in which volunteer subjects are provided a Western style diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods, subjects receive calcium supplements and during the other 4 week inpatient period they receive a placebo tablet. The researchers determine changes within the colon as a result of supplementing the vitamin D in the presence of high and low calcium. A more detailed description of the study is provided below.
Read the detailed description
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 week inpatient period. During the inpatient periods, the Rockefeller University Hospital (RUH) becomes your home. The subject must sleep here every night and consume all the food provided. During the screening visit, blood and urine samples will be taken and an EKG (electrocardiogram) and a complete physical exam will be done. After enrollment into the study, the first 4 week inpatient period begins. You may continue to go to work or do other activities as long as you eat the diet provided and sleep at the Rockefeller University Hospital. You must eat everything that we give you and you may not substitute or supplement the diet in any way. During each 4 week stay at the Rockefeller University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes. In addition, blood samples will be taken every few days for follow-up and research, and two 24 hour urine samples will be done on separate days during the hospitalization. Vital signs are measured every day and your weight will be measured three times per week. During the four week wash out period, the subject will return to their home, go about their normal activities and consume their normal diet. The subject will return to the Rockefeller University Hospital for the second 4 week inpatient period. The procedures and laboratory tests are the same during the second inpatient period. The study concludes with the subjects' discharge from the RUH.
- Conditions
- Colorectal Polyps, Colorectal Adenoma, Adenocarcinoma
- Being tested
- placebo and Calcitriol, Calcium and Calcitriol
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo and CalcitriolDrug
Placebo tablets twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
Calcium and CalcitriolDrug
Calcium twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
| Study group | Role | What they receive |
|---|---|---|
| placebo and Calcitriol | Placebo comparator | placebo tablets together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol) Receives: Drug: placebo and Calcitriol |
| 2 | Active comparator | calcium together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol) Receives: Drug: Calcium and Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression related to proliferation, apoptosis, and differentiation of human rectal mucosal cells
Measured: end of study
Secondary outcomes (1)
Expression of additional genes involved in the cell properties noted above
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Holt, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298545
- Sponsor's protocol ID
- RUH IRB # PHO-0554
- Status last verified
- Nov 2011
- First submitted
- 1 Mar 2006
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Protiva P, Pendyala S, Nelson C, Augenlicht LH, Lipkin M, Holt PR. Calcium and 1,25-dihydroxyvitamin D3 modulate genes of immune and inflammatory pathways in the human colon: a human crossover trial. Am J Clin Nutr. 2016 May;103(5):1224-31. doi: 10.3945/ajcn.114.105304. Epub 2016 Mar 23.
PubMed 27009752
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High vs. Low Calcium Intake in the Presence of High Vitamin D: Effect on Gene Expression in the Colon
- ClinicalTrials.gov ID
- NCT00298545
- Acronym / sponsor ID
- RUH IRB # PHO-0554
- Conditions
- Colorectal Polyps, Colorectal Adenoma, Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Mar 2006 (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.
The researchers are involved in a research program to understand how vitamin D and calcium in the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end, the researchers are conducting a study of vitamin D supplementation in which volunteer subjects are provided a Western style diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods, subjects receive calcium supplements and during the other 4 week inpatient period they receive a placebo tablet. The researchers determine changes within the colon as a result of supplementing the vitamin D in the presence of high and low calcium. A more detailed description of the study is provided below.
Detailed description
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 week inpatient period. During the inpatient periods, the Rockefeller University Hospital (RUH) becomes your home. The subject must sleep here every night and consume all the food provided. During the screening visit, blood and urine samples will be taken and an EKG (electrocardiogram) and a complete physical exam will be done. After enrollment into the study, the first 4 week inpatient period begins. You may continue to go to work or do other activities as long as you eat the diet provided and sleep at the Rockefeller University Hospital. You must eat everything that we give you and you may not substitute or supplement the diet in any way. During each 4 week stay at the Rockefeller University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes. In addition, blood samples will be taken every few days for follow-up and research, and two 24 hour urine samples will be done on separate days during the hospitalization. Vital signs are measured every day and your weight will be measured three times per week. During the four week wash out period, the subject will return to their home, go about their normal activities and consume their normal diet. The subject will return to the Rockefeller University Hospital for the second 4 week inpatient period. The procedures and laboratory tests are the same during the second inpatient period. The study concludes with the subjects' discharge from the RUH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo and Calcitriol | Placebo comparator | Drug: placebo and Calcitriolplacebo tablets together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol) |
| 2 | Active comparator | Drug: Calcium and Calcitriolcalcium together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol) |
Who may qualify
- Ages
- 48 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers with a history of pre-cancerous colorectal polyps and/or have a family history of pre-cancerous polyps or colon cancer
- Not taking any medications known to affect either calcium metabolism or colon function
- Between the ages of 48 and 72 years old
- Have had pre-cancerous colorectal polyps or have first or second degree relatives with colorectal cancer and are therefore at increased risk for the disease
Key exclusion criteria (28 listed)
- Personal history of cancer other than non-melanoma skin cancer
- Diseases of the bowel such as intestinal malabsorption or inflammatory bowel disease
- Prior gastrointestinal surgery including gastrectomy, small or large bowel resections. (If one has had an appendectomy or surgery of the esophagus, he/she is still eligible.)
- Any excessive bleeding or clotting disorders
- Taking blood thinners
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 |
|---|---|---|
| placebo and CalcitriolPlacebo tablets twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol) | Drug | placebo and Calcitriol |
| Calcium and CalcitriolCalcium twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol) | Drug | 2 |
Primary outcome
Gene expression related to proliferation, apoptosis, and differentiation of human rectal mucosal cells
Time frame: end of study
1 secondary outcome
Expression of additional genes involved in the cell properties noted above
Time frame: end of study
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 18 Nov 2011.
- Derived from this study: PubMed 27009752Protiva P, Pendyala S, Nelson C, Augenlicht LH, Lipkin M, Holt PR. Calcium and 1,25-dihydroxyvitamin D3 modulate genes of immune and inflammatory pathways in the human colon: a human crossover trial. Am J Clin Nutr. 2016 May;103(5):1224-31. doi: 10.3945/ajcn.114.105304. Epub 2016 Mar 23.
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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.
Peter Holt, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium and Calcitriol in people with Colorectal Polyps and Colorectal Adenoma, run by Rockefeller University 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 4 inclusion and 28 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 18 Nov 2011. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Gene expression related to proliferation, apoptosis, and differentiation of human rectal mucosal cells (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298545, which also lists 1 linked publication.
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 18 Nov 2011.