Vitamin D DeficiencyNCT01537809
Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
A study testing Vitamin D3 in people with Vitamin D Deficiency, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 691 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2013
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects in 4th-8th grade
- Subjects must attend school where study is being conducted
- Subject and parent/guardian must give assent/consent to participate in study Related Requirements
- Subjects must complete all study visits (baseline, 3,6 and 12 months)
- Subjects must agree to be blinded
Who cannot join
- Subjects taking glucocorticoids
- Subjects not in 4th-8th grade
- Clinical diagnosis of Cystic Fibrosis
- Clinical diagnosis of Kidney disease
- Subjects currently taking a vitamin D supplement of >1000 IU/day
- Subjects diagnosed with Irritable Bowel Syndrome (IBS)
Show all 9Show fewer
- Clinical diagnosis of AIDS
- Clinical diagnosis of Sarcoidosis
- Clinical diagnosis of Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren
The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.
Read the detailed description
Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3
- Keywords
- Vitamin D, Vitamin D Deficiency, Avitaminosis, Deficiency Diseases, Blood lipids
- Medical subject headings
- Vitamin D Deficiency, Avitaminosis, Deficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Subjects are told to take vitamin D daily for 6 months.
Vitamin D3Dietary supplement
Subjects are asked to take vitamin D orally, daily for six months.
| Study group | Role | What they receive |
|---|---|---|
| D3 600 IU/ daily | Active comparator | Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months. Receives: Dietary Supplement: Vitamin D3 |
| D3 1000 IU/ daily | Active comparator | Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months. Receives: Dietary Supplement: Vitamin D3 |
| D3: 2000 IU/daily | Active comparator | Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D levels over six month period
Subjects will be randomized to receive one of three doses of vitamin D3. Baseline serum 25(OH)D levels will be compared to serum 25(OH)D at 3 and 6 months.
Safety Issue?: (FDAAA) No
Measured: Six months
Secondary outcomes (1)
measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status
Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Heart, Lung, and Blood Institute (NHLBI), Boston University, Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Jennifer Sacheck, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537809
- Sponsor's protocol ID
- 1103016
- Other IDs
- 3R01HL106160
- Status last verified
- Dec 2013
- First submitted
- 17 Feb 2012
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sacheck J, Goodman E, Chui K, Chomitz V, Must A, Economos C. Vitamin D deficiency, adiposity, and cardiometabolic risk in urban schoolchildren. J Pediatr. 2011 Dec;159(6):945-50. doi: 10.1016/j.jpeds.2011.06.001. Epub 2011 Jul 23.
PubMed 21784451Sacheck JM, Huang Q, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Gordon CM, Goodman E. Vitamin D supplementation and cardiometabolic risk factors among diverse schoolchildren: a randomized clinical trial. Am J Clin Nutr. 2022 Jan 11;115(1):73-82. doi: 10.1093/ajcn/nqab319.
PubMed 34550329Blakeley CE, Van Rompay MI, Schultz NS, Sacheck JM. Relationship between muscle strength and dyslipidemia, serum 25(OH)D, and weight status among diverse schoolchildren: a cross-sectional analysis. BMC Pediatr. 2018 Feb 2;18(1):23. doi: 10.1186/s12887-018-0998-x.
PubMed 29394922Sacheck JM, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Goodman E, Gordon CM, Holick MF. Impact of Three Doses of Vitamin D3 on Serum 25(OH)D Deficiency and Insufficiency in At-Risk Schoolchildren. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4496-4505. doi: 10.1210/jc.2017-01179.
PubMed 29029097Sawicki CM, Van Rompay MI, Au LE, Gordon CM, Sacheck JM. Sun-Exposed Skin Color Is Associated with Changes in Serum 25-Hydroxyvitamin D in Racially/Ethnically Diverse Children. J Nutr. 2016 Apr;146(4):751-7. doi: 10.3945/jn.115.222505. Epub 2016 Mar 2.
PubMed 26936138Van Rompay MI, McKeown NM, Goodman E, Eliasziw M, Chomitz VR, Gordon CM, Economos CD, Sacheck JM. Sugar-Sweetened Beverage Intake Is Positively Associated with Baseline Triglyceride Concentrations, and Changes in Intake Are Inversely Associated with Changes in HDL Cholesterol over 12 Months in a Multi-Ethnic Sample of Children. J Nutr. 2015 Oct;145(10):2389-95. doi: 10.3945/jn.115.212662. Epub 2015 Sep 2.
PubMed 26338888
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren
- ClinicalTrials.gov ID
- NCT01537809
- Acronym / sponsor ID
- 1103016
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Vitamin D Deficiency, Avitaminosis, Deficiency Diseases, Blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Heart, Lung, and Blood Institute (NHLBI), Boston University, Boston Children's Hospital
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Feb 2012 (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.
The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.
Detailed description
Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D3 600 IU/ daily | Active comparator | Dietary Supplement: Vitamin D3Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months. |
| D3 1000 IU/ daily | Active comparator | Dietary Supplement: Vitamin D3Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months. |
| D3: 2000 IU/daily | Active comparator | Dietary Supplement: Vitamin D3Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects in 4th-8th grade
- Subjects must attend school where study is being conducted
- Subject and parent/guardian must give assent/consent to participate in study Related Requirements
- Subjects must complete all study visits (baseline, 3,6 and 12 months)
- Subjects must agree to be blinded
Key exclusion criteria (9 listed)
- Subjects taking glucocorticoids
- Subjects not in 4th-8th grade
- Clinical diagnosis of Cystic Fibrosis
- Clinical diagnosis of Kidney disease
- Subjects currently taking a vitamin D supplement of >1000 IU/day
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 D3Subjects are told to take vitamin D daily for 6 months. | Dietary supplement | D3 1000 IU/ daily, D3 600 IU/ daily, D3: 2000 IU/daily |
| Vitamin D3Subjects are asked to take vitamin D orally, daily for six months. | Dietary supplement | D3 1000 IU/ daily, D3 600 IU/ daily, D3: 2000 IU/daily |
Primary outcome
Change in vitamin D levels over six month period
Time frame: Six months
Subjects will be randomized to receive one of three doses of vitamin D3. Baseline serum 25(OH)D levels will be compared to serum 25(OH)D at 3 and 6 months. Safety Issue?: (FDAAA) No
1 secondary outcome
measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status
Time frame: 12 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 13 Dec 2013.
- Background: PubMed 21784451Sacheck J, Goodman E, Chui K, Chomitz V, Must A, Economos C. Vitamin D deficiency, adiposity, and cardiometabolic risk in urban schoolchildren. J Pediatr. 2011 Dec;159(6):945-50. doi: 10.1016/j.jpeds.2011.06.001. Epub 2011 Jul 23.
- Derived from this study: PubMed 34550329Sacheck JM, Huang Q, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Gordon CM, Goodman E. Vitamin D supplementation and cardiometabolic risk factors among diverse schoolchildren: a randomized clinical trial. Am J Clin Nutr. 2022 Jan 11;115(1):73-82. doi: 10.1093/ajcn/nqab319.
- Derived from this study: PubMed 29394922Blakeley CE, Van Rompay MI, Schultz NS, Sacheck JM. Relationship between muscle strength and dyslipidemia, serum 25(OH)D, and weight status among diverse schoolchildren: a cross-sectional analysis. BMC Pediatr. 2018 Feb 2;18(1):23. doi: 10.1186/s12887-018-0998-x.
- Derived from this study: PubMed 29029097Sacheck JM, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Goodman E, Gordon CM, Holick MF. Impact of Three Doses of Vitamin D3 on Serum 25(OH)D Deficiency and Insufficiency in At-Risk Schoolchildren. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4496-4505. doi: 10.1210/jc.2017-01179.
- Derived from this study: PubMed 26936138Sawicki CM, Van Rompay MI, Au LE, Gordon CM, Sacheck JM. Sun-Exposed Skin Color Is Associated with Changes in Serum 25-Hydroxyvitamin D in Racially/Ethnically Diverse Children. J Nutr. 2016 Apr;146(4):751-7. doi: 10.3945/jn.115.222505. Epub 2016 Mar 2.
- Derived from this study: PubMed 26338888Van Rompay MI, McKeown NM, Goodman E, Eliasziw M, Chomitz VR, Gordon CM, Economos CD, Sacheck JM. Sugar-Sweetened Beverage Intake Is Positively Associated with Baseline Triglyceride Concentrations, and Changes in Intake Are Inversely Associated with Changes in HDL Cholesterol over 12 Months in a Multi-Ethnic Sample of Children. J Nutr. 2015 Oct;145(10):2389-95. doi: 10.3945/jn.115.212662. Epub 2015 Sep 2.
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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.
Jennifer Sacheck, PhD principal investigator
Tufts University
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 D3 in people with Vitamin D Deficiency, run by Tufts 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 5 inclusion and 9 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 13 Dec 2013. 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. 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?
Change in vitamin D levels over six month period (time frame: Six months). 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 NCT01537809, which also lists 6 linked publications.
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 13 Dec 2013.