PeriodontitisIMPROVENCT03148483

Calcium-vitamin D & Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women

A study testing Early PT, Delayed PT and Fortified Milk in people with Periodontitis and Inflammation, run by University of Westminster at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The improvement of maternal and child health remains a key issue in global health. Production and improved accessibility of healthy and nutrient-rich milk-based products could potentially tackle health and nutrition inequalities in low-income countries. Read more about this study

Who is it for?: Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Periodontitis, Inflammation
What is being tested?: Early PT, Delayed PT and Fortified Milk
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteBrazil
Study dates: 24 Apr 2017to 30 May 2018
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 18 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Aged ≥ 18 year;
Up to 16 weeks' gestation;
Having ≥ 20 teeth;
Diagnosis of periodontitis (≥ 1 tooth with at least one of periodontal sites with ≥ 4 mm of clinical attachment loss and bleeding on probing on the same site);
Not received regular dental treatment in the last 6 months (except from those who only visited the dentist for an emergency appointment e.g. tooth extraction);
Cognitively and physically able to complete an interview and oral examination; and
Willing to participate (including provision of blood samples)

Who cannot join

Diagnosis of HIV/AIDS, psychosis, diabetes before pregnancy, thyroid disease, or disorders causing vitamin D hypersensitivity (e.g. sarcoidosis and other lymphomatous disorders);
Diagnosis of lactose intolerance or milk allergy;
History of renal stones or family history of renal stone and hyperparathyroidism;
presence of extensive dental cavity and decay;
Use of antibiotics or any immune-suppressants or medication known to affect vitamin D/calcium metabolism; and
Consumption of ≥4 servings/day of dairy products or taking vitamin D supplements at > 400 IU/day.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Centro Municipal de Saúde de Duque de Caxias & Policlínica Hospital Duque de Caxias
Rio de Janeiro

Other trials in Brazil

About this study

Official title: Calcium and Vitamin D Supplementation and Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women: a Feasibility Trial (THE IMPROVE TRIAL)

This study will assess the acceptability of a multi-component intervention, including provision of calcium/vitamin-D fortified milk and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles. The IMPROVE trial is a feasibility randomised controlled trial (RCT) with parallel qualitative process evaluation. The target population is low-income, pregnant, Brazilian women, with periodontitis, who have not seen a dentist in the last 6 months. A series of focus group discussions and interviews with the target population will be conducted to identify key barriers and enablers to adoption and implementation of the intervention in prenatal clinics in Rio de Janeiro/Brazil. Participants will be allocated to 4 groups: 1) early PT (during pregnancy) plus fortified milk; 2) early PT plus plain milk; 3) delayed PT (after delivery) plus fortified milk; 4) delayed PT plus plain milk.

The final results will contribute to the understanding of the significance of calcium and vitamin D for short and long-term health and the occurrence of diseases, as well as to inform the current global debate on vitamin-D supplementation and fortification policy.

Conditions: Periodontitis, Inflammation
Being tested: Early PT, Delayed PT, Fortified Milk, Plain Milk
Keywords: Pregnancy outcome, Feasibility, Milk Fortification, Periodontitis, Pregnant women, Periodontal Therapy
Medical subject headings: Periodontitis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early PTOther
Also called Early non-surgical periodontal therapy
Women will receive conventional non-surgical periodontal therapy (PT), consisting of prophylactic dental polishing to remove the sticky bacterial film that forms on the teeth over time, scaling and root planing, as necessary throughout pregnancy, up to delivery
Delayed PTOther
Also called Delayed non-surgical periodontal therapy
Women will receive conventional non-surgical PT delayed until after delivery.
Fortified MilkDietary supplement
participants will be advised to take two servings of a powdered milk-based drink enriched with calcium and vitamin D daily during breakfast and afternoon snack or supper to avoid concomitant intake of the prenatal iron supplements routinely prescribed for consumption with hot main meals (e.g. lunch or dinner). Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with 500 IU of vitamin D3 and 1,2 g of a calcium supplement from milk extract (300 mg of calcium) twice a day.
Plain MilkDietary supplement
Also called non-fortified milk (placebo)
Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with flour (placebo).

Study groups in NCT03148483
Study group	Role	What they receive
Early PT plus Fortified Milk	Experimental	early periodontal therapy (during pregnancy) plus fortified milk Receives: Other: Early PT; Dietary Supplement: Fortified Milk
Early PT plus Plain Milk	Experimental	early periodontal therapy (during pregnancy) plus plain milk Receives: Other: Early PT; Dietary Supplement: Plain Milk
Delayed PT plus Fortified Milk	Experimental	delayed periodontal therapy (after delivery) plus fortified milk Receives: Other: Delayed PT; Dietary Supplement: Fortified Milk
Delayed PT plus Plain Milk	Placebo comparator	delayed periodontal therapy (after delivery) plus plain milk Receives: Other: Delayed PT; Dietary Supplement: Plain Milk

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility (acceptability of study design, recruitment strategy, random allocation and data collection procedures)
Feasibility will be evaluated using mixed-methods to explore intervention delivery, participants' acceptability, challenges and issues faced during the study, and recommended changes to the study design.
Focus groups discussions will be held prior to trial recruitment to discuss issues regarding recruitment strategy, study design and data collection. In addition, group discussions will be held throughout the study (2nd and 3rd trimester) to assess potential barriers and facilitators to the intervention and data collection. At the end of each participant's involvement in the study, the participant will be asked to complete an anonymous, acceptability questionnaire to gain insights about participant's reactions to research participation and how acceptable the participant found study requirements and assessments were.
Measured: From baseline till 6-8 weeks' postpartum
Recruitment rate
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 120 participants. Recruitment rate will be calculated (number of participants per month)
Measured: one year
Adherence
number of drop-outs in each study arm. Analyses of drop-out rates (%) in four study arms. Self-reported quantity of milk consumed during the study. Number of follow-up visits. Proportion of participants who provide full data at baseline, throughout pregnancy and up to 6-8 weeks postpartum.
Measured: From baseline till 6-8 weeks' postpartum

Secondary outcomes (9)

Changes in % of sites with bleeding on probing
Certified and calibrated dentists will conduct dental examinations pre/post-intervention. Full mouth periodontal examination will be performed at six sites per tooth, using disposable periodontal probes with coloured-coded area and mirror but without X-rays. Bleeding scores will be determined as percentage of sites with bleeding relative to the total number of sites examined.
Measured: baseline and 6-8 weeks' postpartum
Changes in maternal blood biomarkers to assess inflammation
Blood samples will be taken to assess changes in cytokines levels: CRP, IL-6 and MMP-9.
Measured: 10 months on average
Changes in maternal serum levels of 25(OH)D
Blood samples will be taken to assess changes in 25(OH)D levels
Measured: 10 months on average
Changes in maternal glucose levels
Fasting blood samples will be taken to assess changes in glucose levels
Measured: 10 months on
Changes in maternal insulin levels
Fasting blood samples will be taken to assess changes in insulin levels
Measured: 10 months on average
Changes in maternal serum levels of calcium
Fasting blood samples will be taken to assess changes in calcium levels
Measured: 10 months on average
Changes in maternal blood lipids levels
Fasting blood samples will be taken to assess changes in total cholesterol and HDL-c
Measured: 10 months on average
Neonatal levels of 25(OH)D
drops of neonatal capillary blood will be collected via heel prick (200 μl) for measurement of 25(OH)D concentrations at the routine neonatal check-up
Measured: between 8 to 22 months
Neonatal levels of calcium
drops of neonatal capillary blood will be collected via heel prick (200 μl) for measurement of calcium concentrations
Measured: between 8 to 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201730 May 2018

First posted11 May 2017
Study start24 Apr 2017
Primary completion30 May 2018
Study completion30 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PeriodontitisStudies 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: Factorial
Model description: 2x2 factorial design
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03148483
Sponsor's protocol ID: 2602
Acronym: IMPROVE
Status last verified: Jul 2021
First submitted: 27 Oct 2016
Last updated: 3 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: External users will be bound by a data sharing agreement (in Portuguese and English) which will be available as part of the application to share data on the University website

Publications

Rodrigues Amorim Adegboye A, Cocate PG, Benaim C, da Veiga Soares Carvalho MC, Schlussel MM, de Castro MBT, Kac G, Heitmann BL. Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial. Trials. 2020 Mar 5;21(1):244. doi: 10.1186/s13063-020-4142-5.
PubMed 32138765
Cocate PG, Kac G, Heitmann BL, Nadanovsky P, da Veiga Soares Carvalho MC, Benaim C, Schlussel MM, de Castro MBT, Alves-Santos NH, Baptista AF, Holick MF, Mokhtar RR, Bomfim AR, Adegboye ARA. Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial). Pilot Feasibility Stud. 2019 Mar 5;5:38. doi: 10.1186/s40814-019-0417-6. eCollection 2019.
PubMed 30873290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Calcium and Vitamin D Supplementation and Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women: a Feasibility Trial (THE IMPROVE TRIAL)
ClinicalTrials.gov ID: NCT03148483
Acronym / sponsor ID: IMPROVE / 2602
Conditions: Periodontitis, Inflammation
Keywords: Pregnancy outcome, Feasibility, Milk Fortification, Periodontitis, Pregnant women, Periodontal Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University of WestminsterUniversity, hospital or other
Collaborators: Universidade Federal do Rio de Janeiro, Copenhagen University Hospital, Denmark, Rio de Janeiro State University, Instituto Fernandes Figueira, University of Oxford, Boston University
Study start: 24 Apr 2017 (actual)
Primary completion: 30 May 2018 (actual)
Study completion: 30 May 2018 (actual)
First posted: 11 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 4
Model description: 2x2 factorial design

Arm	Type	Receives
Early PT plus Fortified Milk	Experimental	Other: Early PT, Dietary Supplement: Fortified Milkearly periodontal therapy (during pregnancy) plus fortified milk
Early PT plus Plain Milk	Experimental	Other: Early PT, Dietary Supplement: Plain Milkearly periodontal therapy (during pregnancy) plus plain milk
Delayed PT plus Fortified Milk	Experimental	Other: Delayed PT, Dietary Supplement: Fortified Milkdelayed periodontal therapy (after delivery) plus fortified milk
Delayed PT plus Plain Milk	Placebo comparator	Other: Delayed PT, Dietary Supplement: Plain Milkdelayed periodontal therapy (after delivery) plus plain milk

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Aged ≥ 18 year;
Up to 16 weeks' gestation;
Having ≥ 20 teeth;
Diagnosis of periodontitis (≥ 1 tooth with at least one of periodontal sites with ≥ 4 mm of clinical attachment loss and bleeding on probing on the same site);
Not received regular dental treatment in the last 6 months (except from those who only visited the dentist for an emergency appointment e.g. tooth extraction);

Key exclusion criteria (6 listed)

Diagnosis of HIV/AIDS, psychosis, diabetes before pregnancy, thyroid disease, or disorders causing vitamin D hypersensitivity (e.g. sarcoidosis and other lymphomatous disorders);
Diagnosis of lactose intolerance or milk allergy;
History of renal stones or family history of renal stone and hyperparathyroidism;
presence of extensive dental cavity and decay;
Use of antibiotics or any immune-suppressants or medication known to affect vitamin D/calcium metabolism; and

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
Early PTAlso: Early non-surgical periodontal therapyWomen will receive conventional non-surgical periodontal therapy (PT), consisting of prophylactic dental polishing to remove the sticky bacterial film that forms on the teeth over time, scaling and root planing, as necessary throughout pregnancy, up to delivery	Other	Early PT plus Fortified Milk, Early PT plus Plain Milk
Delayed PTAlso: Delayed non-surgical periodontal therapyWomen will receive conventional non-surgical PT delayed until after delivery.	Other	Delayed PT plus Fortified Milk, Delayed PT plus Plain Milk
Fortified Milkparticipants will be advised to take two servings of a powdered milk-based drink enriched with calcium and vitamin D daily during breakfast and afternoon snack or supper to avoid concomitant intake of the prenatal iron supplements routinely prescribed for consumption with hot main meals (e.g. lunch or dinner). Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with 500 IU of vitamin D3 and 1,2 g of a calcium supplement from milk extract (300 mg of calcium) twice a day.	Dietary supplement	Delayed PT plus Fortified Milk, Early PT plus Fortified Milk
Plain MilkAlso: non-fortified milk (placebo)Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with flour (placebo).	Dietary supplement	Delayed PT plus Plain Milk, Early PT plus Plain Milk

Primary outcome

Feasibility (acceptability of study design, recruitment strategy, random allocation and data collection procedures)
Time frame: From baseline till 6-8 weeks' postpartum
Feasibility will be evaluated using mixed-methods to explore intervention delivery, participants' acceptability, challenges and issues faced during the study, and recommended changes to the study design. Focus groups discussions will be held prior to trial recruitment to discuss issues regarding recruitment strategy, study design and data collection. In addition, group discussions will be held throughout the study (2nd and 3rd trimester) to assess potential barriers and facilitators to the intervention and data collection. At the end of each participant's involvement in the study, the participant will be asked to complete an anonymous, acceptability questionnaire to gain insights about participant's reactions to research participation and how acceptable the participant found study requirements and assessments were.
Recruitment rate
Time frame: one year
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 120 participants. Recruitment rate will be calculated (number of participants per month)
Adherence
Time frame: From baseline till 6-8 weeks' postpartum
number of drop-outs in each study arm. Analyses of drop-out rates (%) in four study arms. Self-reported quantity of milk consumed during the study. Number of follow-up visits. Proportion of participants who provide full data at baseline, throughout pregnancy and up to 6-8 weeks postpartum.

9 secondary outcomes

Changes in % of sites with bleeding on probing
Time frame: baseline and 6-8 weeks' postpartum
Changes in maternal blood biomarkers to assess inflammation
Time frame: 10 months on average
Changes in maternal serum levels of 25(OH)D
Time frame: 10 months on average
Changes in maternal glucose levels
Time frame: 10 months on
Changes in maternal insulin levels
Time frame: 10 months on average
Changes in maternal serum levels of calcium
Time frame: 10 months on average
Changes in maternal blood lipids levels
Time frame: 10 months on average
Neonatal levels of 25(OH)D
Time frame: between 8 to 22 months
Neonatal levels of calcium
Time frame: between 8 to 22 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 3 Aug 2021.
Derived from this study: PubMed 32138765Rodrigues Amorim Adegboye A, Cocate PG, Benaim C, da Veiga Soares Carvalho MC, Schlussel MM, de Castro MBT, Kac G, Heitmann BL. Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial. Trials. 2020 Mar 5;21(1):244. doi: 10.1186/s13063-020-4142-5.
Derived from this study: PubMed 30873290Cocate PG, Kac G, Heitmann BL, Nadanovsky P, da Veiga Soares Carvalho MC, Benaim C, Schlussel MM, de Castro MBT, Alves-Santos NH, Baptista AF, Holick MF, Mokhtar RR, Bomfim AR, Adegboye ARA. Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial). Pilot Feasibility Stud. 2019 Mar 5;5:38. doi: 10.1186/s40814-019-0417-6. eCollection 2019.
Individual participant dataSharing planned: Undecided. External users will be bound by a data sharing agreement (in Portuguese and English) which will be available as part of the application to share data on the University website

Related trials for Periodontitis

Recruiting
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A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
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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 Early PT, Delayed PT and Fortified Milk in people with Periodontitis and Inflammation, run by University of Westminster at 1 site in Brazil.

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 7 inclusion and 6 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 3 Aug 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 Brazil. 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?

Feasibility (acceptability of study design, recruitment strategy, random allocation and data collection procedures) (time frame: From baseline till 6-8 weeks' postpartum). The study lists 3 primary outcomes in all. 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 NCT03148483, which also lists 2 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 3 Aug 2021.