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

University of Westminster

Status: Completed

Conditions: Periodontitis; Inflammation

Treatments: Other: Delayed PT; Other: Early PT; Dietary Supplement: Plain Milk; Dietary Supplement: Fortified Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT03148483

2602

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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70 participants in 4 patient groups, including a placebo group

Early PT plus Fortified Milk

Experimental group

Description:

early periodontal therapy (during pregnancy) plus fortified milk

Treatment:

Other: Early PT

Dietary Supplement: Fortified Milk

Early PT plus Plain Milk

Experimental group

Description:

early periodontal therapy (during pregnancy) plus plain milk

Treatment:

Dietary Supplement: Plain Milk

Other: Early PT

Delayed PT plus Fortified Milk

Experimental group

Description:

delayed periodontal therapy (after delivery) plus fortified milk

Treatment:

Dietary Supplement: Fortified Milk

Other: Delayed PT

Delayed PT plus Plain Milk

Placebo Comparator group

Description:

delayed periodontal therapy (after delivery) plus plain milk

Treatment:

Dietary Supplement: Plain Milk

Other: Delayed PT