Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren
2 other identifiers
interventional
691
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 13, 2013
December 1, 2013
2.5 years
February 17, 2012
December 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
12 months
Study Arms (3)
D3 600 IU/ daily
ACTIVE COMPARATORSubjects randomized to 600 IU/day of vitamin D3 taken orally for six months.
D3 1000 IU/ daily
ACTIVE COMPARATORSubjects randomized to 1000 IU/day of vitamin D3 taken orally for six months.
D3: 2000 IU/daily
ACTIVE COMPARATORSubjects randomized to 2000 IU/day of vitamin D3 taken orally for six months.
Interventions
Subjects are told to take vitamin D daily for 6 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Clinical diagnosis of AIDS
- Clinical diagnosis of Sarcoidosis
- Clinical diagnosis of Epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- Office of Dietary Supplements (ODS)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Boston Universitycollaborator
- Boston Children's Hospitalcollaborator
Study Sites (1)
Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (6)
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.
PMID: 21784451BACKGROUNDSacheck 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.
PMID: 34550329DERIVEDBlakeley 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.
PMID: 29394922DERIVEDSacheck 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.
PMID: 29029097DERIVEDSawicki 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.
PMID: 26936138DERIVEDVan 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.
PMID: 26338888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Sacheck, PhD
Tufts University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
February 23, 2012
Study Start
June 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 13, 2013
Record last verified: 2013-12