Vitamin D DeficiencyNCT01971411
Vitamin D Deficiency in Elderly African American Women in Central Texas
An observational study of Vitamin D Deficiency and Osteoporosis, run by McLennan County Medical Education and Research Foundation at 1 site in United States.
Trial summary
In order to make bone health a reality for older adults, we need to consider the prevalence of Vitamin D deficiency in relation to environment latitude as well as vitamin D supplementation. Darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Osteoporosis, Osteopenia
- What is being tested?
- Calcium 500mg with 200 IU Vitamin D - 2 tablets daily, Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH and Usual sun exposure documentation
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 2007
- Phase
- Observational
- 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 70 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Study population: African American females aged 70 years or older and non-institutionalized
Who may be able to join
- Age 70 or older woman
- African American ethnicity
- Non-institutionalized
Who cannot join
- De-compensated hepatic insufficiency
- Renal insufficiency with GFR estimated to be < 30 ml/min
- Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome.
- Institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
In order to make bone health a reality for older adults, we need to consider the prevalence of Vitamin D deficiency in relation to environment latitude as well as vitamin D supplementation. Darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document vitamin D deficiency in elderly African American women living in a southern latitude.
Read the detailed description
Summary: Since darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D, we hypothesize that: 1) the usual sun exposure in the southern United States may not be sufficient to maintain adequate vitamin D levels in elderly African American women, 2) recommended supplementation of Vitamin D 400 IU/d may not be adequate to prevent Vitamin D deficiency which in turn could lead to calcium deficiency and possibly sub-clinical hyperparathyroidism.
This study will enroll 60 African American women age 65 or older who do not have renal, hepatic or gastrointestinal disorders that could affect Vitamin D and calcium absorption and metabolism. Patients will have two scheduled office visits. Demographic data will be collected with attention to dietary intake of calcium and vitamin D, and the patient's customary degree of sun exposure. Ca, 25-hydroxyvitamin D, PTH and serum CTX (a bone resorption marker) are measured on enrollment day and repeated 6 weeks later. All patients not already taking 1000 mg Calcium with 400 IU of Vitamin D orally daily were given samples of this supplement to last for 6 weeks without making any change in diet or sun exposure recommendations. The study period will extend April to June - a time when there should be ample sunlight but it is not so hot as to stop the elderly from going outdoors. Statistical analysis will be performed as to the effect(s) of ethnic background, age, diet, and intensity of sun exposure as related to Ca, 25-hydroxyvitamin D, PTH and serum CTX.
- Conditions
- Vitamin D Deficiency, Osteoporosis, Osteopenia
- Being tested
- Calcium 500mg with 200 IU Vitamin D - 2 tablets daily, Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH, Usual sun exposure documentation, Dietary intake of calcium, vitamin D, magnesium
- Keywords
- Hyperparathyroidism, Hypoparathyroidism, Calcium, Vitamin D, Bone mineral density, African American, Female, Elderly
- Medical subject headings
- Vitamin D Deficiency, Osteoporosis, Bone Diseases, Metabolic, Hyperparathyroidism, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium 500mg with 200 IU Vitamin D - 2 tablets dailyDrug
Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTHProcedure or surgery
Usual sun exposure documentationBehavioural
Dietary intake of calcium, vitamin D, magnesiumBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Community dwelling elderly black females | Not described Receives: Drug: Calcium 500mg with 200 IU Vitamin D - 2 tablets daily; Procedure: Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH; Behavioral: Usual sun exposure documentation; Behavioral: Dietary intake of calcium, vitamin D, magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: 6 week period in 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startMar 2006
- Primary completionMay 2007
- Study completionMay 2007
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 Vitamin D DeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- McLennan County Medical Education and Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Sally P Weaver, PhD, MD, Principal investigator, McLennan County Medical Educ. and Research FoundationH. S. Eugene Fung, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971411
- Sponsor's protocol ID
- VIT.D.DEF.1
- Status last verified
- Mar 2018
- First submitted
- 23 Apr 2013
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weaver SP, Passmore C, Collins B, Fung E. Vitamin D, sunlight exposure, and bone density in elderly African American females of low socioeconomic status. Fam Med. 2010 Jan;42(1):47-51.
PubMed 20063223
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in Elderly African American Women in Central Texas
- ClinicalTrials.gov ID
- NCT01971411
- Acronym / sponsor ID
- VIT.D.DEF.1
- Conditions
- Vitamin D Deficiency, Osteoporosis, Osteopenia
- Keywords
- Hyperparathyroidism, Hypoparathyroidism, Calcium, Vitamin D, Bone mineral density, African American, Female, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- McLennan County Medical Education and Research FoundationUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Mar 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 29 Oct 2013 (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.
In order to make bone health a reality for older adults, we need to consider the prevalence of Vitamin D deficiency in relation to environment latitude as well as vitamin D supplementation. Darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document vitamin D deficiency in elderly African American women living in a southern latitude.
Detailed description
Summary: Since darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D, we hypothesize that: 1) the usual sun exposure in the southern United States may not be sufficient to maintain adequate vitamin D levels in elderly African American women, 2) recommended supplementation of Vitamin D 400 IU/d may not be adequate to prevent Vitamin D deficiency which in turn could lead to calcium deficiency and possibly sub-clinical hyperparathyroidism.
This study will enroll 60 African American women age 65 or older who do not have renal, hepatic or gastrointestinal disorders that could affect Vitamin D and calcium absorption and metabolism. Patients will have two scheduled office visits. Demographic data will be collected with attention to dietary intake of calcium and vitamin D, and the patient's customary degree of sun exposure. Ca, 25-hydroxyvitamin D, PTH and serum CTX (a bone resorption marker) are measured on enrollment day and repeated 6 weeks later. All patients not already taking 1000 mg Calcium with 400 IU of Vitamin D orally daily were given samples of this supplement to last for 6 weeks without making any change in diet or sun exposure recommendations. The study period will extend April to June - a time when there should be ample sunlight but it is not so hot as to stop the elderly from going outdoors. Statistical analysis will be performed as to the effect(s) of ethnic background, age, diet, and intensity of sun exposure as related to Ca, 25-hydroxyvitamin D, PTH and serum CTX.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community dwelling elderly black females | – | Drug: Calcium 500mg with 200 IU Vitamin D - 2 tablets daily, Procedure: Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH, Behavioral: Usual sun exposure documentation, Behavioral: Dietary intake of calcium, vitamin D, magnesium |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- African American females aged 70 years or older and non-institutionalized
Key inclusion criteria (3 listed)
- Age 70 or older woman
- African American ethnicity
- Non-institutionalized
Key exclusion criteria (4 listed)
- De-compensated hepatic insufficiency
- Renal insufficiency with GFR estimated to be < 30 ml/min
- Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome.
- Institutionalized
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 |
|---|---|---|
| Calcium 500mg with 200 IU Vitamin D - 2 tablets daily | Drug | Community dwelling elderly black females |
| Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH | Procedure or surgery | Community dwelling elderly black females |
| Usual sun exposure documentation | Behavioural | Community dwelling elderly black females |
| Dietary intake of calcium, vitamin D, magnesium | Behavioural | Community dwelling elderly black females |
Primary outcome
Bone mineral density
Time frame: 6 week period in 2007
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 30 Mar 2018.
- Results publication: PubMed 20063223Weaver SP, Passmore C, Collins B, Fung E. Vitamin D, sunlight exposure, and bone density in elderly African American females of low socioeconomic status. Fam Med. 2010 Jan;42(1):47-51.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Sally P Weaver, PhD, MD principal investigator
McLennan County Medical Educ. and Research Foundation
H. S. Eugene Fung, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Osteoporosis, run by McLennan County Medical Education and Research Foundation 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 4 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 30 Mar 2018. 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.
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?
Bone mineral density (time frame: 6 week period in 2007). 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 NCT01971411, 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 30 Mar 2018.