Vitamin D DeficiencyPhase 2NCT03193944
Vitamin D Supplementation on Metabolic Syndrome Indicators Among Older Adults, Alborz Province, Iran
A Phase 2 study testing D-vitin, soft gelatin capsule (vitamin D3,50000 IU) in people with Vitamin D Deficiency and Diabetes Mellitus, run by Alborz Medical University at 1 site in Iran.
Trial summary
General objective: To assess the effect of vitamin D supplementation on metabolic syndrome among food insecure and vitamin D deficient older adults in Karaj city, Alborz province in Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting participants. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Diabetes Mellitus, Hypertension
- What is being tested?
- D-vitin, soft gelatin capsule (vitamin D3,50000 IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 10 Feb 2017to 10 Jul 2017
- Phase
- Phase 2
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Food insecure,
- Have fit criteria of metabolic syndrome; (WC>90 cm), obesity (BMI≥30 kg/m2), diabetes (FBS>100 mg/dl), high blood pressure (systolic >135 mmHg and diastolic >85 mmHg) and dyslipidaemia (LDL≥ 240 mg/dl, HDL<40 mg/dl, TC≥ 160 mg/dl; TG≥ 200 mg/dl),
- Vitamin D deficient; serum 25(OH) D level <30 ng/ml,
- No use of vitamin D supplementation before 60 days,
Who cannot join
- An inability or unwillingness to participate,
- Those who are already taking any type of vitamin D supplements,
- Individuals with a history of allergy,
- Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc.,
- Illness that required corticosteroids or insulin,
- Drugs are known to influence vitamin D level; steroids, anti-acids, oestrogen,
- People with conditions that contradict vitamin D supplementation, for example, a history of hypercalcaemia, hepatic disease or renal stones, sarcoidosis, or malignancy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation on Metabolic Syndrome Indicators Among Food Insecure, Vitamin D Deficient Older Adults in Karaj City, Alborz Province, Iran;
General objective: To assess the effect of vitamin D supplementation on metabolic syndrome among food insecure and vitamin D deficient older adults in Karaj city, Alborz province in Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting participants. Inclusion Criteria: Food insecure, metabolic syndrome; Vitamin D deficiency Exclusion Criteria: those who are already taking any type of vitamin D supplements, Individuals with a history of allergy, Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc., Intervention group: The intervention will start from 10 of May 2017 to 11 of July 2017 for 2 months. The intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks plus pamphlets and brochures about nutrition and health at the beginning of the study. Control group: The respondents in control group will receive placebo plus brochures and pamphlets related to nutrition and health at the beginning of the study. The data collection process will identify the older adults for both groups; intervention and control. Consent will be obtained from those who are eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups. Primary Output: Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l. Secondary Output: Reduction anthropometry (body mass index (BMI) and waist circumference (WC), Improved Biomarkers indicators (lipid profile, fasting blood fast), improved blood pressure before and after intervention.
Read the detailed description
This study aims to find relationships between food insecurity, vitamin D intakes and its impact on metabolic syndrome among older adults in a city in Alborz province in Iran, known as Karaj. This study has 2 parts; the first part is to determine the prevalence of food insecurity and vitamin D deficiency among older adults in Karaj city. The second part is an intervention study examining effects of vitamin D supplementation on metabolic syndrome (diabetes, obesity, hypertension, and dyslipidaemia) among older adults who have at least have risk factors of metabolic syndrome, food insecure and vitamin D deficient. The first part; the data collection process will be performed in a few stages. The first stage will be to initiate contacting with the health centres in Karaj city to identify the older adults. Appointments will be set after screening the study subjects who will be eligible. Consent will be obtained from those who were eligible. The preliminary information on demographic data, socioeconomics, food insecurity, dietary intake and sunlight exposure will be collected by using a set of questionnaires. The blood sample for measuring serum 25 (OH) D will be taken the same day as questionnaires were filled.
The second stage: The data collection process will be performed in few stages. The first stage will include of contact with health centres in Karaj city to identify the older adults for both groups; intervention and control. Consent will be obtained from those who will eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups.
- Conditions
- Vitamin D Deficiency, Diabetes Mellitus, Hypertension, Lipid Metabolism Disorders, Obesity, Abdominal
- Being tested
- D-vitin, soft gelatin capsule (vitamin D3,50000 IU), Placebo vitamin D3
- Medical subject headings
- Vitamin D Deficiency, Diabetes Mellitus, Hypertension, Lipid Metabolism Disorders, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-vitin, soft gelatin capsule (vitamin D3,50000 IU)Drug
Also called cholecalciferol,
Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health.
Placebo vitamin D3Drug
vitamin D as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks Receives: Drug: D-vitin, soft gelatin capsule (vitamin D3,50000 IU) |
| control group | Placebo comparator | Control group will receive vitamin D as a placebo. placebo will be identical in appearance taste and odourless. Receives: Drug: Placebo vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l.
According to the guidline, vitamin D deficiency will improve by taking vitamin D3 by 2 months.
Measured: by 2 months
Secondary outcomes (4)
Reduction anthropometry (BMI and WC),
Reduction of BMI, WC after 2 months intervention by vitamin D3
Measured: by 2 months
Improved Biomarker indicators (lipid profile)
Reduction of lipid profiles are important for this research after vitamin D3 intervention.
Measured: by 2 months
Improved Biomarker indicator FBS
Reduction of FBS by 2 months intervention via taking vitamin D
Measured: by 2 months
Improved blood pressure
Reduction of blood pressure after taking vitamin D for 2 months
Measured: by 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start10 Feb 2017
- Primary completion10 May 2017
- Study completion10 Jul 2017
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A detailed explanation on research design, location and population, sampling technique, sample size, instrument, data collection, data analysis and potential limitations of the study are outlined in the following sections. This study aims to find relationships between food insecurity, vitamin D intakes and its impact on metabolic syndrome among older adults in a city in Alborz province in Iran, known as Karaj. This study has 2 parts; the first part is to determine the prevalence of food insecurity and vitamin D deficiency among older adults in Karaj city. The second part is an intervention study examining effects of vitamin D supplementation on metabolic syndrome (diabetes, obesity, hypertension, and dyslipidaemia) among older adults who has at least have risk factors of metabolic syndrome, food insecure and vitamin D deficient. The intervention group will receive vitamin D supplementation 50000 IU for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alborz Medical University
- Sponsor type
- Other government
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Principal investigator, Maryam Zarei, Alborz Medical University
- Investigators
- Zarei, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193944
- Sponsor's protocol ID
- Abzums.Rec.1395.114
- Status last verified
- Jan 2018
- First submitted
- 13 Jun 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation on Metabolic Syndrome Indicators Among Food Insecure, Vitamin D Deficient Older Adults in Karaj City, Alborz Province, Iran;
- ClinicalTrials.gov ID
- NCT03193944
- Acronym / sponsor ID
- Abzums.Rec.1395.114
- Conditions
- Vitamin D Deficiency, Diabetes Mellitus, Hypertension, Lipid Metabolism Disorders, Obesity, Abdominal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alborz Medical UniversityOther government
- Collaborators
- Universiti Putra Malaysia
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 21 Jun 2017 (actual)
- 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.
General objective: To assess the effect of vitamin D supplementation on metabolic syndrome among food insecure and vitamin D deficient older adults in Karaj city, Alborz province in Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting participants. Inclusion Criteria: Food insecure, metabolic syndrome; Vitamin D deficiency Exclusion Criteria: those who are already taking any type of vitamin D supplements, Individuals with a history of allergy, Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc., Intervention group: The intervention will start from 10 of May 2017 to 11 of July 2017 for 2 months. The intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks plus pamphlets and brochures about nutrition and health at the beginning of the study. Control group: The respondents in control group will receive placebo plus brochures and pamphlets related to nutrition and health at the beginning of the study. The data collection process will identify the older adults for both groups; intervention and control. Consent will be obtained from those who are eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups. Primary Output: Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l. Secondary Output: Reduction anthropometry (body mass index (BMI) and waist circumference (WC), Improved Biomarkers indicators (lipid profile, fasting blood fast), improved blood pressure before and after intervention.
Detailed description
This study aims to find relationships between food insecurity, vitamin D intakes and its impact on metabolic syndrome among older adults in a city in Alborz province in Iran, known as Karaj. This study has 2 parts; the first part is to determine the prevalence of food insecurity and vitamin D deficiency among older adults in Karaj city. The second part is an intervention study examining effects of vitamin D supplementation on metabolic syndrome (diabetes, obesity, hypertension, and dyslipidaemia) among older adults who have at least have risk factors of metabolic syndrome, food insecure and vitamin D deficient. The first part; the data collection process will be performed in a few stages. The first stage will be to initiate contacting with the health centres in Karaj city to identify the older adults. Appointments will be set after screening the study subjects who will be eligible. Consent will be obtained from those who were eligible. The preliminary information on demographic data, socioeconomics, food insecurity, dietary intake and sunlight exposure will be collected by using a set of questionnaires. The blood sample for measuring serum 25 (OH) D will be taken the same day as questionnaires were filled.
The second stage: The data collection process will be performed in few stages. The first stage will include of contact with health centres in Karaj city to identify the older adults for both groups; intervention and control. Consent will be obtained from those who will eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A detailed explanation on research design, location and population, sampling technique, sample size, instrument, data collection, data analysis and potential limitations of the study are outlined in the following sections. This study aims to find relationships between food insecurity, vitamin D intakes and its impact on metabolic syndrome among older adults in a city in Alborz province in Iran, known as Karaj. This study has 2 parts; the first part is to determine the prevalence of food insecurity and vitamin D deficiency among older adults in Karaj city. The second part is an intervention study examining effects of vitamin D supplementation on metabolic syndrome (diabetes, obesity, hypertension, and dyslipidaemia) among older adults who has at least have risk factors of metabolic syndrome, food insecure and vitamin D deficient. The intervention group will receive vitamin D supplementation 50000 IU for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: D-vitin, soft gelatin capsule (vitamin D3,50000 IU)Intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks |
| control group | Placebo comparator | Drug: Placebo vitamin D3Control group will receive vitamin D as a placebo. placebo will be identical in appearance taste and odourless. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Food insecure,
- Have fit criteria of metabolic syndrome; (WC>90 cm), obesity (BMI≥30 kg/m2), diabetes (FBS>100 mg/dl), high blood pressure (systolic >135 mmHg and diastolic >85 mmHg) and dyslipidaemia (LDL≥ 240 mg/dl, HDL<40 mg/dl, TC≥ 160 mg/dl; TG≥ 200 mg/dl),
- Vitamin D deficient; serum 25(OH) D level <30 ng/ml,
- No use of vitamin D supplementation before 60 days,
Key exclusion criteria (7 listed)
- An inability or unwillingness to participate,
- Those who are already taking any type of vitamin D supplements,
- Individuals with a history of allergy,
- Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc.,
- Illness that required corticosteroids or insulin,
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 |
|---|---|---|
| D-vitin, soft gelatin capsule (vitamin D3,50000 IU)Also: cholecalciferol,Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health. | Drug | Intervention group |
| Placebo vitamin D3vitamin D as a placebo | Drug | control group |
Primary outcome
Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l.
Time frame: by 2 months
According to the guidline, vitamin D deficiency will improve by taking vitamin D3 by 2 months.
4 secondary outcomes
Reduction anthropometry (BMI and WC),
Time frame: by 2 months
Improved Biomarker indicators (lipid profile)
Time frame: by 2 months
Improved Biomarker indicator FBS
Time frame: by 2 months
Improved blood pressure
Time frame: by 2 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 16 Jan 2018.
- Individual participant dataSharing planned: Yes
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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.
Zarei principal investigator
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-vitin, soft gelatin capsule (vitamin D3,50000 IU) in people with Vitamin D Deficiency and Diabetes Mellitus, run by Alborz Medical University at 1 site in Iran.
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 7 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 16 Jan 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l. (time frame: by 2 months). 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 16 Jan 2018.