OverweightNCT05376865
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
A study testing Vitamin D supplement in people with Overweight and Hypovitaminosis D, run by Tirang R. Neyestani, Ph.D. at 1 site in Iran.
Trial summary
46 eligible overweight women with hypovitaminosis D are assigned to either vitamin D or control group using block randomization method. Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) containing 50000 IU cholecalciferol or placebo are administered weekly for 12 weeks. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Hypovitaminosis D
- What is being tested?
- Vitamin D supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIran
- Study dates
- 29 Sep 2021to 20 Feb 2022
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- low serum vitamin D level <30ng/ml
- 25<BMI<30 kg/m2
- Age: 20-50
- Free of chronic diseased such as cancer, diabetes, cardiovascular disease, renal diseases, gastrointestinal diseases, no multivitamin supplement intake, no change in weight in the last 3 months
Who cannot join
- Getting pregnant during the study
- Suffering from thyroid disorders and other diseases mentioned during the study
- Not taking supplements weekly
Trial locations and contacts
1 site in 1 country.
Iran1 site
Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Tehran
About this study
Official title: The Interactive Effect of Vitamin D3 Supplementation and Vitamin D Receptor Polymorphisms on Obesity, Inflammatory and Metabolic Markers in Overweight Women With Hypovitaminosis D
46 eligible overweight women with hypovitaminosis D are assigned to either vitamin D or control group using block randomization method. Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) containing 50000 IU cholecalciferol or placebo are administered weekly for 12 weeks. Participants in both groups are structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study.
Read the detailed description
For the randomized controlled clinical trial (RCT), the first fifty eligible women were assigned to either the vitamin D or placebo group using the block randomization method. Each Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) contained 50000 IU cholecalciferol and was administered weekly for 12 weeks according to guidelines for treating vitamin D deficiency. Placebo pearls (Zahravi Pharma Co, Tabriz, Iran) had the identical appearance, taste, and smell as the vitamin D pearls and could only be identified by the package code. The placebo pearls were administered similarly. To keep the study double-blinded, an assistant who was not involved in assessments managed the randomization and supplement assignment procedure. Participants were structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study. They were also asked to inform the researcher before taking any new medications. All participants were provided with a moderately reduced diet (a reduction of 300 kcal per day) based on their basal weight. The nutrigenetic study investigated 75 eligible women (including the vitamin D group and the last fifty women who entered the study). The nutrigenetic study protocol was the same as that mentioned above for the vitamin D group in the RCT. Compliance was ensured by weekly text messages and voice calls to remind the users of the supplement on the given day. In addition, the supplement and placebo pearls were presented in two visits; once at the baseline visit and then after six weeks. Pearls packs were collected from each subject (at week 6 and week 12) to check if all the pearls were consumed as recommended.
During the first and last visits, anthropometric and laboratory assessments were performed for all subjects. The primary outcomes are improving anthropometric, inflammatory, and metabolic markers of overweight women with hypovitaminosis D.
- Conditions
- Overweight, Hypovitaminosis D
- Being tested
- Vitamin D supplement
- Medical subject headings
- Overweight, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementDietary supplement
The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Vitamin D3 supplement every week Receives: Dietary Supplement: Vitamin D supplement |
| Control | Placebo comparator | Placebo every week Receives: Dietary Supplement: Vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D
Fasting serum 25-hydroxyvitamin D level
Measured: 12 weeks
Weight
Subject's weight wearing light clothing
Measured: 12 weeks
Secondary outcomes (9)
Waist circumference
the measurement at the midpoint between the lowest rib and the iliac crest
Measured: 12 weeks
Fat mass
Total body fat mass measured by Bioelectrical Impedance analysis method
Measured: 12 weeks
Serum Fasting Glucose
Fasting serum glucose level
Measured: 12 weeks
Serum total cholesterol
Fasting serum total cholesterol level
Measured: 12 weeks
Serum triglyceride
Fasting serum triglyceride level Fasting serum triglyceride leve
Measured: 12 weeks
Serum hsCRP
Fasting serum high sensitivity c-reactive protein level
Measured: 12 weeks
Serum IL-6
Fasting serum Interleukin-6 level
Measured: 12 weeks
Serum TNF-a
Fasting serum tumor necrosis factor alpha level
Measured: 12 weeks
Serum PTH
Fasting serum parathyroid hormone level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start29 Sep 2021
- Primary completion29 Dec 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tirang R. Neyestani, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Sponsor-investigator, Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376865
- Sponsor's protocol ID
- 26
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interactive Effect of Vitamin D3 Supplementation and Vitamin D Receptor Polymorphisms on Obesity, Inflammatory and Metabolic Markers in Overweight Women With Hypovitaminosis D
- ClinicalTrials.gov ID
- NCT05376865
- Acronym / sponsor ID
- 26
- Conditions
- Overweight, Hypovitaminosis D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tirang R. Neyestani, Ph.D.University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 17 May 2022 (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.
46 eligible overweight women with hypovitaminosis D are assigned to either vitamin D or control group using block randomization method. Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) containing 50000 IU cholecalciferol or placebo are administered weekly for 12 weeks. Participants in both groups are structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study.
Detailed description
For the randomized controlled clinical trial (RCT), the first fifty eligible women were assigned to either the vitamin D or placebo group using the block randomization method. Each Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) contained 50000 IU cholecalciferol and was administered weekly for 12 weeks according to guidelines for treating vitamin D deficiency. Placebo pearls (Zahravi Pharma Co, Tabriz, Iran) had the identical appearance, taste, and smell as the vitamin D pearls and could only be identified by the package code. The placebo pearls were administered similarly. To keep the study double-blinded, an assistant who was not involved in assessments managed the randomization and supplement assignment procedure. Participants were structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study. They were also asked to inform the researcher before taking any new medications. All participants were provided with a moderately reduced diet (a reduction of 300 kcal per day) based on their basal weight. The nutrigenetic study investigated 75 eligible women (including the vitamin D group and the last fifty women who entered the study). The nutrigenetic study protocol was the same as that mentioned above for the vitamin D group in the RCT. Compliance was ensured by weekly text messages and voice calls to remind the users of the supplement on the given day. In addition, the supplement and placebo pearls were presented in two visits; once at the baseline visit and then after six weeks. Pearls packs were collected from each subject (at week 6 and week 12) to check if all the pearls were consumed as recommended.
During the first and last visits, anthropometric and laboratory assessments were performed for all subjects. The primary outcomes are improving anthropometric, inflammatory, and metabolic markers of overweight women with hypovitaminosis D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Vitamin D supplementVitamin D3 supplement every week |
| Control | Placebo comparator | Dietary Supplement: Vitamin D supplementPlacebo every week |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- low serum vitamin D level <30ng/ml
- 25<BMI<30 kg/m2
- Age: 20-50
- Free of chronic diseased such as cancer, diabetes, cardiovascular disease, renal diseases, gastrointestinal diseases, no multivitamin supplement intake, no change in weight in the last 3 months
Key exclusion criteria (3 listed)
- Getting pregnant during the study
- Suffering from thyroid disorders and other diseases mentioned during the study
- Not taking supplements weekly
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 supplementThe intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly. | Dietary supplement | Control, Intervention |
Primary outcome
Serum 25(OH)D
Time frame: 12 weeks
Fasting serum 25-hydroxyvitamin D level
Weight
Time frame: 12 weeks
Subject's weight wearing light clothing
9 secondary outcomes
Waist circumference
Time frame: 12 weeks
Fat mass
Time frame: 12 weeks
Serum Fasting Glucose
Time frame: 12 weeks
Serum total cholesterol
Time frame: 12 weeks
Serum triglyceride
Time frame: 12 weeks
Serum hsCRP
Time frame: 12 weeks
Serum IL-6
Time frame: 12 weeks
Serum TNF-a
Time frame: 12 weeks
Serum PTH
Time frame: 12 weeks
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 17 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 supplement in people with Overweight and Hypovitaminosis D, run by Tirang R. Neyestani, Ph.D. 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 3 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 17 May 2022. 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.
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?
Serum 25(OH)D (time frame: 12 weeks). 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 17 May 2022.