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

NCT03148483 | Completed

• 1 other identifier: 2602
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Inflammation

Keywords

Pregnancy outcome; Feasibility; Milk Fortification; Periodontitis; Pregnant women; Periodontal Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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.

  From baseline till 6-8 weeks' postpartum

Secondary Outcomes (9)

• Changes in % of sites with bleeding on probing

  baseline and 6-8 weeks' postpartum

• Changes in maternal blood biomarkers to assess inflammation

  10 months on average

• Changes in maternal serum levels of 25(OH)D

  10 months on average

• Changes in maternal glucose levels

  10 months on

• Changes in maternal insulin levels

  10 months on average

Study Arms (4)

Early PT plus Fortified Milk

EXPERIMENTAL

early periodontal therapy (during pregnancy) plus fortified milk

Other: Early PT; Dietary Supplement: Fortified Milk

Early PT plus Plain Milk

EXPERIMENTAL

early periodontal therapy (during pregnancy) plus plain milk

Other: Early PT; Dietary Supplement: Plain Milk

Delayed PT plus Fortified Milk

EXPERIMENTAL

delayed periodontal therapy (after delivery) plus fortified milk

Other: Delayed PT; Dietary Supplement: Fortified Milk

Delayed PT plus Plain Milk

PLACEBO COMPARATOR

delayed periodontal therapy (after delivery) plus plain milk

Other: Delayed PT; Dietary Supplement: Plain Milk

Interventions

Early PT OTHER

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

Also known as: Early non-surgical periodontal therapy

Early PT plus Fortified Milk; Early PT plus Plain Milk

Delayed PT OTHER

Women will receive conventional non-surgical PT delayed until after delivery.

Also known as: Delayed non-surgical periodontal therapy

Delayed PT plus Fortified Milk; Delayed PT plus Plain Milk

Fortified Milk DIETARY_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.

Delayed PT plus Fortified Milk; Early PT plus Fortified Milk

Plain Milk DIETARY_SUPPLEMENT

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).

Also known as: non-fortified milk (placebo)

Delayed PT plus Plain Milk; Early PT plus Plain Milk

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Westminster: lead
• Universidade Federal do Rio de Janeiro: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Rio de Janeiro State University: collaborator
• Instituto Fernandes Figueira: collaborator
• University of Oxford: collaborator
• Boston University: collaborator

Study Sites (1)

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

Rio de Janeiro, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32138765 DERIVED

• 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.

  PMID: 30873290 DERIVED

MeSH Terms

Conditions

Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Principal Investigator

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: May 11, 2017
• Study Start: April 24, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: August 3, 2021

Record last verified: 2021-07

Locations

BR (1)