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

NCT ID: NCT03148483

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2018-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early PT plus Fortified Milk

early periodontal therapy (during pregnancy) plus fortified milk

Group Type: EXPERIMENTAL

Early PT

Intervention Type: 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

Fortified Milk

Intervention Type: 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.

Early PT plus Plain Milk

early periodontal therapy (during pregnancy) plus plain milk

Group Type: EXPERIMENTAL

Early PT

Intervention Type: 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

Plain Milk

Intervention Type: 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).

Delayed PT plus Fortified Milk

delayed periodontal therapy (after delivery) plus fortified milk

Group Type: EXPERIMENTAL

Delayed PT

Intervention Type: OTHER

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

Fortified Milk

Intervention Type: 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 Plain Milk

delayed periodontal therapy (after delivery) plus plain milk

Group Type: PLACEBO_COMPARATOR

Delayed PT

Intervention Type: OTHER

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

Plain Milk

Intervention Type: 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).

Interventions

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

Intervention Type: OTHER

Delayed PT

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

Intervention Type: OTHER

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.

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Early non-surgical periodontal therapy; Delayed non-surgical periodontal therapy; non-fortified milk (placebo)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital, Denmark

OTHER

Sponsor Role: collaborator

Rio de Janeiro State University

OTHER

Sponsor Role: collaborator

Instituto Fernandes Figueira

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

University of Westminster

OTHER

Sponsor Role: lead

Responsible Party

Amanda Rodrigues Amorim Adegboye

Senior Lecturer, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rio de Janeiro, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32138765 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30873290 (View on PubMed)

Other Identifiers

2602

Identifier Type: -

Identifier Source: org_study_id