Calcium-vitamin D & Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women
- Conditions
- InflammationPeriodontitis
- Interventions
- Other: Early PTOther: Delayed PTDietary Supplement: Fortified MilkDietary Supplement: Plain Milk
- Registration Number
- NCT03148483
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Early PT plus Fortified Milk Fortified Milk early periodontal therapy (during pregnancy) plus fortified milk Early PT plus Plain Milk Early PT early periodontal therapy (during pregnancy) plus plain milk Early PT plus Plain Milk Plain Milk early periodontal therapy (during pregnancy) plus plain milk Early PT plus Fortified Milk Early PT early periodontal therapy (during pregnancy) plus fortified milk Delayed PT plus Fortified Milk Fortified Milk delayed periodontal therapy (after delivery) plus fortified milk Delayed PT plus Plain Milk Delayed PT delayed periodontal therapy (after delivery) plus plain milk Delayed PT plus Plain Milk Plain Milk delayed periodontal therapy (after delivery) plus plain milk Delayed PT plus Fortified Milk Delayed PT delayed periodontal therapy (after delivery) plus fortified milk
- Primary Outcome Measures
Name Time Method Adherence 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.
Feasibility (acceptability of study design, recruitment strategy, random allocation and data collection procedures) 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 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)
- Secondary Outcome Measures
Name Time Method Changes in maternal glucose levels 10 months on Fasting blood samples will be taken to assess changes in glucose levels
Changes in maternal serum levels of calcium 10 months on average Fasting blood samples will be taken to assess changes in calcium levels
Changes in maternal serum levels of 25(OH)D 10 months on average Blood samples will be taken to assess changes in 25(OH)D levels
Changes in maternal insulin levels 10 months on average Fasting blood samples will be taken to assess changes in insulin levels
Neonatal levels of 25(OH)D 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
Changes in % of sites with bleeding on probing 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.
Neonatal levels of calcium between 8 to 22 months drops of neonatal capillary blood will be collected via heel prick (200 μl) for measurement of calcium concentrations
Changes in maternal blood biomarkers to assess inflammation 10 months on average Blood samples will be taken to assess changes in cytokines levels: CRP, IL-6 and MMP-9.
Changes in maternal blood lipids levels 10 months on average Fasting blood samples will be taken to assess changes in total cholesterol and HDL-c
Trial Locations
- Locations (1)
Centro Municipal de Saúde de Duque de Caxias & Policlínica Hospital Duque de Caxias
🇧🇷Rio de Janeiro, Brazil