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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148483
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : August 3, 2021
Sponsor:
Collaborators:
Universidade Federal do Rio de Janeiro
Copenhagen University Hospital, Denmark
Rio de Janeiro State University
Instituto Fernandes Figueira
University of Oxford
Boston University
Information provided by (Responsible Party):
Amanda Rodrigues Amorim Adegboye, University of Westminster

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Periodontitis Inflammation Other: Early PT Other: Delayed PT Dietary Supplement: Fortified Milk Dietary Supplement: Plain Milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 factorial design
Masking: Single (Participant)
Masking Description:

This is a multi-component intervention. The participants will be blinded for the milk fortification component of the intervention only.

Participants will receive daily sachets with similar appearance either with vitamin D and calcium (intervention) or flour (control).

Primary Purpose: Treatment
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)
Actual Study Start Date : April 24, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early PT plus Fortified Milk
early periodontal therapy (during pregnancy) plus fortified milk
Other: Early PT
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
Other Name: Early non-surgical periodontal therapy

Dietary Supplement: Fortified Milk
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.

Experimental: Early PT plus Plain Milk
early periodontal therapy (during pregnancy) plus plain milk
Other: Early PT
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
Other Name: Early non-surgical periodontal therapy

Dietary Supplement: Plain Milk
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).
Other Name: non-fortified milk (placebo)

Experimental: Delayed PT plus Fortified Milk
delayed periodontal therapy (after delivery) plus fortified milk
Other: Delayed PT
Women will receive conventional non-surgical PT delayed until after delivery.
Other Name: Delayed non-surgical periodontal therapy

Dietary Supplement: Fortified Milk
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.

Placebo Comparator: Delayed PT plus Plain Milk
delayed periodontal therapy (after delivery) plus plain milk
Other: Delayed PT
Women will receive conventional non-surgical PT delayed until after delivery.
Other Name: Delayed non-surgical periodontal therapy

Dietary Supplement: Plain Milk
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).
Other Name: non-fortified milk (placebo)




Primary Outcome Measures :
  1. 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.


  2. 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)

  3. 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.


Secondary Outcome Measures :
  1. Changes in % of sites with bleeding on probing [ Time Frame: baseline and 6-8 weeks' postpartum ]
    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.

  2. Changes in maternal blood biomarkers to assess inflammation [ Time Frame: 10 months on average ]
    Blood samples will be taken to assess changes in cytokines levels: CRP, IL-6 and MMP-9.

  3. Changes in maternal serum levels of 25(OH)D [ Time Frame: 10 months on average ]
    Blood samples will be taken to assess changes in 25(OH)D levels

  4. Changes in maternal glucose levels [ Time Frame: 10 months on ]
    Fasting blood samples will be taken to assess changes in glucose levels

  5. Changes in maternal insulin levels [ Time Frame: 10 months on average ]
    Fasting blood samples will be taken to assess changes in insulin levels

  6. Changes in maternal serum levels of calcium [ Time Frame: 10 months on average ]
    Fasting blood samples will be taken to assess changes in calcium levels

  7. Changes in maternal blood lipids levels [ Time Frame: 10 months on average ]
    Fasting blood samples will be taken to assess changes in total cholesterol and HDL-c

  8. Neonatal levels of 25(OH)D [ Time Frame: between 8 to 22 months ]
    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

  9. Neonatal levels of calcium [ Time Frame: between 8 to 22 months ]
    drops of neonatal capillary blood will be collected via heel prick (200 μl) for measurement of calcium concentrations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148483


Locations
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Brazil
Centro Municipal de Saúde de Duque de Caxias & Policlínica Hospital Duque de Caxias
Rio de Janeiro, Brazil
Sponsors and Collaborators
University of Westminster
Universidade Federal do Rio de Janeiro
Copenhagen University Hospital, Denmark
Rio de Janeiro State University
Instituto Fernandes Figueira
University of Oxford
Boston University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amanda Rodrigues Amorim Adegboye, Senior Lecturer, Principal Investigator, University of Westminster
ClinicalTrials.gov Identifier: NCT03148483    
Other Study ID Numbers: 2602
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amanda Rodrigues Amorim Adegboye, University of Westminster:
Pregnancy outcome
Feasibility
Milk Fortification
Periodontitis
Pregnant women
Periodontal Therapy
Additional relevant MeSH terms:
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Periodontitis
Inflammation
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases