Vitamin D DeficiencyNCT00882505
Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
A study testing vitamin D in people with Vitamin D Deficiency, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2010
- 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 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal Caucasian women, ages 18-47
- Subjects in good health
- Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks
Who cannot join
- Pregnancy and lactation
- Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
- Subjects with hypocholesterolemia and primary hyperparathyroidism
- Subjects taking the following medications:
- Steroids
- Orlistat
Show all 12Show fewer
- Lipid lowering medication: cholestyramine, statins
- Antiepileptic drugs: phenobarbital and phenytoin
- Currently on vitamin D supplements or using any medication contain vitamin D i.e. cod liver oil, topical calcipotriol or history of use within 1 month
- Rifampicin, isoniazid
- Ketoconazole
- Subjects currently on UV therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
The objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels.
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D, Placebo
- 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.
vitamin DDietary supplement
Subject will receive vitamin d supplements
PlaceboOther
Subject will receive a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplement | Experimental | Receive vitamin D supplements. Receives: Dietary Supplement: vitamin D |
| Placebo | Placebo comparator | Receive placebo pills Receives: Other: Placebo |
| Tanning bed user | No intervention | Regular tanning bed users will be assessed for their vitamin D levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
Measured: 3 months
For the comparative study, the primary outcome measure is comparison of the vitamin D level for tanning bed users compared to the level for non-tanning bed users.
Measured: 3 months
Secondary outcomes (1)
The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.
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 posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2010
- Study completionAug 2010
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 Northwestern 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882505
- Sponsor's protocol ID
- STU8461
- Status last verified
- Nov 2021
- First submitted
- 15 Apr 2009
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00882505
- Acronym / sponsor ID
- STU8461
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Apr 2009 (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 objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplement | Experimental | Dietary Supplement: vitamin DReceive vitamin D supplements. |
| Placebo | Placebo comparator | Other: PlaceboReceive placebo pills |
| Tanning bed user | No intervention | –Regular tanning bed users will be assessed for their vitamin D levels. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal Caucasian women, ages 18-47
- Subjects in good health
- Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks
Key exclusion criteria (12 listed)
- Pregnancy and lactation
- Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
- Subjects with hypocholesterolemia and primary hyperparathyroidism
- Subjects taking the following medications:
- Subjects currently on UV therapy
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 DSubject will receive vitamin d supplements | Dietary supplement | Vitamin D supplement |
| PlaceboSubject will receive a placebo. | Other | Placebo |
Primary outcome
For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
Time frame: 3 months
For the comparative study, the primary outcome measure is comparison of the vitamin D level for tanning bed users compared to the level for non-tanning bed users.
Time frame: 3 months
1 secondary outcome
The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.
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 2 Dec 2021.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Vitamin D Deficiency, run by Northwestern 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 3 inclusion and 12 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 2 Dec 2021. 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.
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?
For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 2 Dec 2021.