Overweight and ObesityNCT03134417
Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
A study testing Vitamin D and magnesium and Vitamin D in people with Overweight and Obesity and Vitamin D Deficiency, run by Drexel University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of a combined vitamin D and magnesium supplementation on parathyroid hormone and cardiometabolic health in persons living with obesity. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Vitamin D Deficiency, Magnesium Deficiency
- What is being tested?
- Vitamin D and magnesium and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 1 Jun 2021
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI range 25-40 kg/m2
- 30-70 years of age
Who cannot join
- Presence of any acute illness in the past month
- Pre-existing chronic medical conditions or medications know to influence energy, vitamin D, magnesium and calcium metabolism, levels of blood glucose, lipids and blood pressure
- Individuals taking vitamin D and magnesium supplement greater than the Recommended Daily allowance
- Participants taking any medications or have disease known to influence calcium or bone metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University Nutrition Sciences Research Lab
Philadelphia, Pennsylvania, 19102
About this study
Official title: Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation
The purpose of this study is to investigate the effects of a combined vitamin D and magnesium supplementation on parathyroid hormone and cardiometabolic health in persons living with obesity.
Read the detailed description
Individuals living with obesity are at a higher risk of cardiometabolic abnormalities and high circulating parathyroid hormone. There is evidence suggesting that vitamin D may play a role in cardiovascular health outcomes; however, the research is currently inconclusive. Magnesium is a cofactor of vitamin D metabolism, and the prevalence of concurrent vitamin D and magnesium deficiency is high. This study aims to investigate the effect of vitamin D and magnesium supplements in individuals who are overweight and obese on parathyroid hormone and cardiometabolic health.
- Conditions
- Overweight and Obesity, Vitamin D Deficiency, Magnesium Deficiency, Cardiovascular Risk Factor
- Being tested
- Vitamin D and magnesium, Vitamin D, Placebo
- Medical subject headings
- Overweight, Obesity, Vitamin D Deficiency, Magnesium Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and magnesiumDietary supplement
Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.
Vitamin DDietary supplement
Daily vitamin D supplements are given to participants daily for 12 weeks.
PlaceboDietary supplement
Daily placebo are given to participants daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and magnesium | Experimental | Daily oral vitamin D (1000 IU) and magnesium (360 mg) supplement Receives: Dietary Supplement: Vitamin D and magnesium |
| Vitamin D | Active comparator | Daily oral vitamin D (1000 IU) supplement Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Daily oral placebo (cellulose) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum parathyroid hormone
Measured: 12 weeks
Secondary outcomes (4)
Inflammatory cytokines
Measured: 12 weeks
Lipid profile
Measured: 12 weeks
Blood pressure
Measured: 12 weeks
Serum osteocalcin
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 posted1 May 2017
- Study start1 Feb 2016
- Primary completion31 Dec 2020
- Study completion1 Jun 2021
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 Overweight and ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134417
- Sponsor's protocol ID
- 1407002973
- Status last verified
- Sep 2021
- First submitted
- 7 Apr 2017
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dall RD, Cheung MM, Shewokis PA, Altasan A, Volpe SL, Amori R, Singh H, Sukumar D. Combined vitamin D and magnesium supplementation does not influence markers of bone turnover or glycemic control: A randomized controlled clinical trial. Nutr Res. 2023 Feb;110:33-43. doi: 10.1016/j.nutres.2022.12.005. Epub 2022 Dec 22.
PubMed 36640582
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation
- ClinicalTrials.gov ID
- NCT03134417
- Acronym / sponsor ID
- 1407002973
- Conditions
- Overweight and Obesity, Vitamin D Deficiency, Magnesium Deficiency, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 1 May 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.
The purpose of this study is to investigate the effects of a combined vitamin D and magnesium supplementation on parathyroid hormone and cardiometabolic health in persons living with obesity.
Detailed description
Individuals living with obesity are at a higher risk of cardiometabolic abnormalities and high circulating parathyroid hormone. There is evidence suggesting that vitamin D may play a role in cardiovascular health outcomes; however, the research is currently inconclusive. Magnesium is a cofactor of vitamin D metabolism, and the prevalence of concurrent vitamin D and magnesium deficiency is high. This study aims to investigate the effect of vitamin D and magnesium supplements in individuals who are overweight and obese on parathyroid hormone and cardiometabolic health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and magnesium | Experimental | Dietary Supplement: Vitamin D and magnesiumDaily oral vitamin D (1000 IU) and magnesium (360 mg) supplement |
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DDaily oral vitamin D (1000 IU) supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily oral placebo (cellulose) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI range 25-40 kg/m2
- 30-70 years of age
Key exclusion criteria (4 listed)
- Presence of any acute illness in the past month
- Pre-existing chronic medical conditions or medications know to influence energy, vitamin D, magnesium and calcium metabolism, levels of blood glucose, lipids and blood pressure
- Individuals taking vitamin D and magnesium supplement greater than the Recommended Daily allowance
- Participants taking any medications or have disease known to influence calcium or bone metabolism
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 and magnesiumDaily vitamin D and magnesium supplements are given to participants daily for 12 weeks. | Dietary supplement | Vitamin D and magnesium |
| Vitamin DDaily vitamin D supplements are given to participants daily for 12 weeks. | Dietary supplement | Vitamin D |
| PlaceboDaily placebo are given to participants daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Serum parathyroid hormone
Time frame: 12 weeks
4 secondary outcomes
Inflammatory cytokines
Time frame: 12 weeks
Lipid profile
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Serum osteocalcin
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 27 Sep 2021.
- Derived from this study: PubMed 36640582Dall RD, Cheung MM, Shewokis PA, Altasan A, Volpe SL, Amori R, Singh H, Sukumar D. Combined vitamin D and magnesium supplementation does not influence markers of bone turnover or glycemic control: A randomized controlled clinical trial. Nutr Res. 2023 Feb;110:33-43. doi: 10.1016/j.nutres.2022.12.005. Epub 2022 Dec 22.
- 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.
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 and magnesium and Vitamin D in people with Overweight and Obesity and Vitamin D Deficiency, run by Drexel University 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 2 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 27 Sep 2021. 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. 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 parathyroid hormone (time frame: 12 weeks). 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 NCT03134417, 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 27 Sep 2021.