InflammationNCT01815047
Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
A study testing Vitamin D3 Supplementation in people with Inflammation and Infection, run by Cornell University at 1 site in United States.
Trial summary
The goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The three specific aims of this study are 1) To address the impact of maternal vitamin D status on inflammation and infections across pregnancy… Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Infection
- What is being tested?
- Vitamin D3 Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to May 2019
- 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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female adolescents between 13 and 18 years of age
- Between 12 and < 30 weeks pregnant
Who cannot join
- HIV-infection
- Eating disorders
- Malabsorption diseases
- Diabetes mellitus
- Gestational diabetes
- Pregnancy induced hypertension or elevated diastolic blood pressure (>110)
Show all 11Show fewer
- Steroid use
- Substance abuse history
- Taking medications known to influence Ca or vitamin D status
- Diagnosis of elevated blood lead concentrations during childhood
- Smokes tobacco
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The three specific aims of this study are 1) To address the impact of maternal vitamin D status on inflammation and infections across pregnancy using retrospective data, 2) To address the impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D status during pregnancy on inflammatory mediators at the level of the placenta.
Read the detailed description
Archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and delivery will be analyzed for inflammatory cytokines. The impact of these inflammatory markers will be assessed by comparing the data to measures of vitamin D (25(OH)D, calcitriol and parathyroid hormone) and infections and inflammatory complications abstracted from medical charts. Placental samples were collected from a subset (n=132) of these pregnant teens and these tissues will be analyzed using genome wide microarray of messenger ribonucleic acid (mRNA) and microRNA (miRNA) related to inflammatory processes. A separate group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a vitamin D supplementation trial. Teens will be randomly assigned to one of two supplements (200 IU D3/d vs. 2000 IU D3/d). Similar to the retrospective analysis, maternal calciotropic hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation (23-28 weeks) and at delivery. Inflammatory processes and infections reported across pregnancy will be evaluated in relation to vitamin D status and inflammatory markers.
- Conditions
- Inflammation, Infection
- Being tested
- Vitamin D3 Supplementation
- Keywords
- Vitamin D, Pregnancy, Inflammation, Infection, Placenta, Cytokine, Microbiome
- Medical subject headings
- Inflammation, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 SupplementationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 200 IU Vitamin D3 | Experimental | A singular daily dose of 200 IU vitamin D3 Receives: Dietary Supplement: Vitamin D3 Supplementation |
| 2000 IU Vitamin D3 | Experimental | A singular daily dose of 2000 IU vitamin D3 Receives: Dietary Supplement: Vitamin D3 Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
Maternal calciotropic hormones (25(OH)D, 1,25(OH)2D, 24,25(OH)2D, and PTH) and inflammatory cytokines (CRP, interleukin [IL]-6 and IL-10 and tumor necrosis factor [TNF]-alpha) will be measured at entry into the study and again at 23-28 weeks gestation and delivery after treatment with 200 IU or 2000 IU D3/d. These measures will be compared to inflammatory processes and infections reported in medical records across pregnancy.
Measured: Entry into study, mid-gestation and delivery
Secondary outcomes (2)
Change in maternal vitamin D status and inflammatory markers in serum
In a retrospective analysis, inflammatory cytokines (CRP, IL- 6 and IL-10 and TNF-alpha) in archived serum collected from a cohort of 158 adolescents that were longitudinally followed across pregnancy both at mid-gestation and at delivery will be related to 25-hydroxyvitamin D (25(OH)D), 1,25- dihydroxyvitamin D (1,25(OH)2D) and parathyroid hormone (PTH) and medically treated infections and inflammatory conditions abstracted from medical records.
Measured: Mid-gestation and delivery
Association of maternal vitamin D status (25(OH)D concentration with longitudinal change in 1,25(OH)2D, PTH, 24,25(OH)2D,and the vitamin D metabolite ratio
Measured: Mid-gestation and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionMay 2019
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 InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Kimberly O'Brien, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815047
- Sponsor's protocol ID
- IRB 1201002753
- Other IDs
- USDA 2012-67017-30216
- Status last verified
- Oct 2019
- First submitted
- 11 Mar 2013
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Best CM, Pressman EK, Queenan RA, Cooper E, Vermeylen F, O'Brien KO. Gestational Age and Maternal Serum 25-hydroxyvitamin D Concentration Interact to Affect the 24,25-dihydroxyvitamin D Concentration in Pregnant Adolescents. J Nutr. 2018 Jun 1;148(6):868-875. doi: 10.1093/jn/nxy043.
PubMed 29796622
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
- ClinicalTrials.gov ID
- NCT01815047
- Acronym / sponsor ID
- IRB 1201002753
- Conditions
- Inflammation, Infection
- Keywords
- Vitamin D, Pregnancy, Inflammation, Infection, Placenta, Cytokine, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 20 Mar 2013 (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 goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The three specific aims of this study are 1) To address the impact of maternal vitamin D status on inflammation and infections across pregnancy using retrospective data, 2) To address the impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D status during pregnancy on inflammatory mediators at the level of the placenta.
Detailed description
Archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and delivery will be analyzed for inflammatory cytokines. The impact of these inflammatory markers will be assessed by comparing the data to measures of vitamin D (25(OH)D, calcitriol and parathyroid hormone) and infections and inflammatory complications abstracted from medical charts. Placental samples were collected from a subset (n=132) of these pregnant teens and these tissues will be analyzed using genome wide microarray of messenger ribonucleic acid (mRNA) and microRNA (miRNA) related to inflammatory processes. A separate group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a vitamin D supplementation trial. Teens will be randomly assigned to one of two supplements (200 IU D3/d vs. 2000 IU D3/d). Similar to the retrospective analysis, maternal calciotropic hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation (23-28 weeks) and at delivery. Inflammatory processes and infections reported across pregnancy will be evaluated in relation to vitamin D status and inflammatory markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 IU Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 SupplementationA singular daily dose of 200 IU vitamin D3 |
| 2000 IU Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 SupplementationA singular daily dose of 2000 IU vitamin D3 |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female adolescents between 13 and 18 years of age
- Between 12 and < 30 weeks pregnant
Key exclusion criteria (11 listed)
- HIV-infection
- Eating disorders
- Malabsorption diseases
- Diabetes mellitus
- Gestational diabetes
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 D3 Supplementation | Dietary supplement | 200 IU Vitamin D3, 2000 IU Vitamin D3 |
Primary outcome
Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
Time frame: Entry into study, mid-gestation and delivery
Maternal calciotropic hormones (25(OH)D, 1,25(OH)2D, 24,25(OH)2D, and PTH) and inflammatory cytokines (CRP, interleukin [IL]-6 and IL-10 and tumor necrosis factor [TNF]-alpha) will be measured at entry into the study and again at 23-28 weeks gestation and delivery after treatment with 200 IU or 2000 IU D3/d. These measures will be compared to inflammatory processes and infections reported in medical records across pregnancy.
2 secondary outcomes
Change in maternal vitamin D status and inflammatory markers in serum
Time frame: Mid-gestation and delivery
Association of maternal vitamin D status (25(OH)D concentration with longitudinal change in 1,25(OH)2D, PTH, 24,25(OH)2D,and the vitamin D metabolite ratio
Time frame: Mid-gestation and delivery
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 28 Oct 2019.
- Derived from this study: PubMed 29796622Best CM, Pressman EK, Queenan RA, Cooper E, Vermeylen F, O'Brien KO. Gestational Age and Maternal Serum 25-hydroxyvitamin D Concentration Interact to Affect the 24,25-dihydroxyvitamin D Concentration in Pregnant Adolescents. J Nutr. 2018 Jun 1;148(6):868-875. doi: 10.1093/jn/nxy043.
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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.
Kimberly O'Brien, PhD principal investigator
Cornell 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 Supplementation in people with Inflammation and Infection, run by Cornell 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 11 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 28 Oct 2019. 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 status, infections and inflammation across pregnancy after Vitamin D supplementation (time frame: Entry into study, mid-gestation and delivery). 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 NCT01815047, 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 28 Oct 2019.