title: Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes.
  
  
  METHODS
  The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16.
  
  
  CONCLUSIONS
  The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus.
  
  
  BACKGROUND
  Sri Lanka Clinical Trial Registry: SLCTR/2012/010.
authors: Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. priyanga.ranasinghe@gmail.com
authors: Priyanga
authors: P
authors: Ranasinghe
authors: Ranil
authors: R
authors: Jayawardena
authors: A S A D
authors: AS
authors: Pigera
authors: Prasad
authors: P
authors: Katulanda
authors: Godwin R
authors: GR
authors: Constantine
authors: Priyadarshani
authors: P
authors: Galappaththy
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001066:Appetite / Q000187:drug effects; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D002214:Capsules; D002985:Clinical Protocols; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011236:Prediabetic State / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012107:Research Design; D013188:Sri Lanka; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult; D019287:Zinc Sulfate / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D002214:Capsules; D006442:Glycated Hemoglobin; D007328:Insulin; D008055:Lipids; D019287:Zinc Sulfate; C517652:hemoglobin A1c protein, human