Clinical trial NCT03148483: Calcium-vitamin D & Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Inflammation
Keywords: Pregnancy outcome
Feasibility
Milk Fortification
Periodontitis
Pregnant women
Periodontal Therapy
Lead sponsor: University of Westminster
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
name: Copenhagen University Hospital, Denmark
name: Rio de Janeiro State University
name: Instituto Fernandes Figueira
name: University of Oxford
name: Boston University
First posted: 2017-05-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility (acceptability of study design, recruitment strategy, random allocation and data collection procedures)
timeFrame: From baseline till 6-8 weeks' postpartum
measure: Recruitment rate
timeFrame: one year
measure: Adherence
timeFrame: From baseline till 6-8 weeks' postpartum
Secondary outcomes:
measure: Changes in % of sites with bleeding on probing
timeFrame: baseline and 6-8 weeks' postpartum
measure: Changes in maternal blood biomarkers to assess inflammation
timeFrame: 10 months on average
measure: Changes in maternal serum levels of 25(OH)D
timeFrame: 10 months on average
measure: Changes in maternal glucose levels
timeFrame: 10 months on
measure: Changes in maternal insulin levels
timeFrame: 10 months on average
measure: Changes in maternal serum levels of calcium
timeFrame: 10 months on average
measure: Changes in maternal blood lipids levels
timeFrame: 10 months on average
measure: Neonatal levels of 25(OH)D
timeFrame: between 8 to 22 months
measure: Neonatal levels of calcium
timeFrame: between 8 to 22 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Centro Municipal de Saúde de Duque de Caxias & Policlínica Hospital Duque de Caxias
Study officials:
References:
citation: 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.
citation: 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.