Deficiency of Vitamin D3VDAWNCT02921204
Dietary Intake and Vitamin D Level in Adult Women
An observational study of Deficiency of Vitamin D3, run by Princess Nourah Bint Abdulrahman University.
Trial summary
Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia. Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are thought to be at greater risk for vitamin D deficiency because of their darker skin type and the likelihood of reduced ultraviolet… Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Deficiency of Vitamin D3
- What is being tested?
- Vitamin D status
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pre and post-menopausal women 35-55 years of age who were able to provide a 24 hour dietary record.
Who may be able to join
- Women 35- 55 years old,
- Women who spoke Arabic language fluently, and
- Women who were willing to fill a 24-hour questionnaire and provide a serum sample for measurements.
Who cannot join
- Women < 35 years old or > 55 years old.
About this study
Official title: Study is to Assess the Effect of Dietary Intake of Nutrients and Level of Vitamin D in Women
Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia. Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are thought to be at greater risk for vitamin D deficiency because of their darker skin type and the likelihood of reduced ultraviolet exposure . The present study entitled, "Dietary Intake and Vitamin D Level in adult Women," was formulated as there is paucity of data on the etiologic importance of dietary intake in Vitamin D level on blood on women. The major objective of the proposed study is to assess the effect of dietary intake of nutrients and level of vitamin D in women .
Read the detailed description
For this study, the investigators enrolled 168 women 35-55 years old to evaluate Vitamin D status and to determined whether status was correlated with Vitamin D deficiency.
All women completed a self-administered questionnaire about personal socio-demographic characteristics; They all had anthropometric measurements of body mass index and waist circumference. A 24-hour dietary recall was administered to all women.
The proximate analysis of 25 types of food was conducted according to the American Association of Organic Chemists (AOAC) methods. The following parameters were measured: serum calcium. Vitamin D, levels of parathyroid hormone.
- Conditions
- Deficiency of Vitamin D3
- Being tested
- Vitamin D status
- Keywords
- Vitamin D, Calcium, Phytic Acid, body weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D statusOther
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D status | Subjects are recruited to asses Vitamin D status with no interventions Receives: Other: Vitamin D status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D serum levels
Measured: 1 year
Secondary outcomes (2)
Calcium serum levels
Measured: 1 year
Vitamin D and Calcium Intake
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency of Vitamin D3Studies 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
- Cross-sectional
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Principal investigator, Nora ALfaris, Princess Nourah Bint Abdulrahman University
- Investigators
- Amani Aljajani, PhD, Study chair, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921204
- Sponsor's protocol ID
- NON
- Acronym
- VDAW
- Status last verified
- Sep 2016
- First submitted
- 29 Sep 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study is to Assess the Effect of Dietary Intake of Nutrients and Level of Vitamin D in Women
- ClinicalTrials.gov ID
- NCT02921204
- Acronym / sponsor ID
- VDAW / NON
- Conditions
- Deficiency of Vitamin D3
- Keywords
- Vitamin D, Calcium, Phytic Acid, body weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Oct 2016 (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 deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia. Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are thought to be at greater risk for vitamin D deficiency because of their darker skin type and the likelihood of reduced ultraviolet exposure . The present study entitled, "Dietary Intake and Vitamin D Level in adult Women," was formulated as there is paucity of data on the etiologic importance of dietary intake in Vitamin D level on blood on women. The major objective of the proposed study is to assess the effect of dietary intake of nutrients and level of vitamin D in women .
Detailed description
For this study, the investigators enrolled 168 women 35-55 years old to evaluate Vitamin D status and to determined whether status was correlated with Vitamin D deficiency.
All women completed a self-administered questionnaire about personal socio-demographic characteristics; They all had anthropometric measurements of body mass index and waist circumference. A 24-hour dietary recall was administered to all women.
The proximate analysis of 25 types of food was conducted according to the American Association of Organic Chemists (AOAC) methods. The following parameters were measured: serum calcium. Vitamin D, levels of parathyroid hormone.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D status | – | Other: Vitamin D statusSubjects are recruited to asses Vitamin D status with no interventions |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pre and post-menopausal women 35-55 years of age who were able to provide a 24 hour dietary record.
Key inclusion criteria (3 listed)
- Women 35- 55 years old,
- Women who spoke Arabic language fluently, and
- Women who were willing to fill a 24-hour questionnaire and provide a serum sample for measurements.
Key exclusion criteria (1 listed)
- Women < 35 years old or > 55 years old.
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 D statusThere is no intervention in this study | Other | Vitamin D status |
Primary outcome
Vitamin D serum levels
Time frame: 1 year
2 secondary outcomes
Calcium serum levels
Time frame: 1 year
Vitamin D and Calcium Intake
Time frame: 1 year
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 3 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Amani Aljajani, PhD study chair
Princess Nourah Bint Abdulrahman University
Questions about this trial
What is this clinical trial studying?
An observational study of Deficiency of Vitamin D3, run by Princess Nourah Bint Abdulrahman University.
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 1 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 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Vitamin D serum levels (time frame: 1 year). 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 3 Oct 2016.