Dietary Intake and Vitamin D Level in Adult Women (VDAW)

September 30, 2016 updated by: Nora ALfaris, Princess Nourah Bint Abdulrahman University

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pre and post-menopausal women 35-55 years of age who were able to provide a 24 hour dietary record.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women < 35 years old or > 55 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vitamin D status
Subjects are recruited to asses Vitamin D status with no interventions
Other: Vitamin D status
There is no intervention in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vitamin D serum levels
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Calcium serum levels
Time Frame: 1 year
1 year
Vitamin D and Calcium Intake
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Exposure to sun
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Nourah Bint Abdulrahman University

Collaborators

University of Connecticut

Investigators

  • Study Chair: Amani Aljajani, PhD, Princess Nourah Bint Abdulrahman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • non (Other Identifier: non)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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