Calcium and Vitamin D Supplementation and Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women: a Feasibility Trial (THE IMPROVE TRIAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Westminster
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- 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).
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
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.
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)
Secondary Outcomes
- Changes in maternal glucose levels(10 months on)
- Changes in maternal serum levels of calcium(10 months on average)
- Changes in maternal serum levels of 25(OH)D(10 months on average)
- Changes in maternal insulin levels(10 months on average)
- Neonatal levels of 25(OH)D(between 8 to 22 months)
- Changes in % of sites with bleeding on probing(baseline and 6-8 weeks' postpartum)
- Neonatal levels of calcium(between 8 to 22 months)
- Changes in maternal blood biomarkers to assess inflammation(10 months on average)
- Changes in maternal blood lipids levels(10 months on average)
Investigators
Amanda Rodrigues Amorim Adegboye
Senior Lecturer, Principal Investigator
University of Westminster