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Effects of Zinc supplementation on pre-diabetes:A double-blind, randomized, placebo-controlled trial

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SLCTR Registration Number

SLCTR/2012/010

Date of Registration

15 Nov 2012

The date of last modification

Mar 03, 2019

Trial Status


Application Summary

Scientific Title of Trial

Effects of Zinc supplementation on pre-diabetes:A double-blind, randomized, placebo-controlled trial

Public Title of Trial

Effects of Zinc supplementation on diabetes prevention

Disease or Health Condition(s) Studied

Type 2 Diabetes Mellitus

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

UTN: U1111-1138-4033

Any other number(s) assigned to the trial and issuing authority

EC-11-189 (ERC - University of Colombo)


Trial Details

What is the research question being addressed?

Will supplementation of Zinc (20mg) improve dysglyceamia in pre-diabetes?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Not Available

Intervention(s) planned

  1. Participants will be randomly and equally assigned into the test and placebo groups considering age, gender. 2.They will receive either one capsule of 20mg elemental Zinc or an identical placebo daily for a period of 12 months 3.Their anthropometric parameters (height, weight, BMI, waist circumference, hip circumference) will be recorded at the baseline and at the end of study. 4. Biochemical assessments (fasting blood glucose, OGTT, serum insulin, lipid profile, serum Zinc, and HbA1c) will be done at the 0, 1, 3, 6 and 12 months. 5. Dietary assessment would be done at baseline and during each monthly visit. 6. Socio-demographic data, drugs and data on side effects would also be gathered via a questionnaire 7. Pharmacokinetics parameters of zinc in blood would be assessed with specified time intervals after oral administration of zinc in a subset of the above population

Inclusion criteria

  1. Age 18 years – 60 years 2. Fasting Blood Glucose (FBG) between 110-125mg/dl or 2-hr Post Oral Glucose Blood Glucose (OGTT) between 140-199mg/dl or both

Exclusion criteria

  1. Patients on any vitamin or mineral supplementation 2.Current use of a weight loss medicine or dietary modification. 3. Alcohol consumption > 20 g/day 4.Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.

Primary outcome(s)

1.

Improvement of glycaemic control by Zinc supplementation using the following parameters:

1.Fasting Blood Glucose 2. Post Oral Glucose Blood Glucose 3. HbA1C 4. Serum Insulin

 [

At baseline, 1, 3, 6 and 12 months

]

Secondary outcome(s)

1.

Lipid profile

[

At baseline, 1, 3, 6 and 12 months

]
2.

Anthropometric assessment

[

At baseline, 1, 3, 6 and 12 months

]
3.

Insulin resistance (using HOMA: Homeostatic Model Assessment of Insulin Resistance)

 [

At baseline, 1, 3, 6 and 12 months

]

Target number/sample size

200

Countries of recruitment

Sri Lanka

Anticipated start date

2012-12-01

Anticipated end date

2012-06-30

Date of first enrollment

2013-01-01

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

National Science Foundation (NSF/2011/HS/01)

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2012-08-16

Approval number

EC-11-189

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr Priyanga Ranasinghe ,
Lecturer
Department of Pharmacology Faculty of Medicine, University of Colombo

0714-039413

priyanga.ranasinghe@gmail.com

Contact Person for Public Queries

Dr Priyadarshani Galappaththi
Senior Lecturer, Department of Pharmacology
Department of Pharmacology Faculty of Medicine, University of Colombo
0112-695300 (ext 198)


priyadarshani1232000@yahoo.com

Primary study sponsor/organization

National Science Foundation

47/5, Maitland Place, Colombo 07.
011 2696771 011 2694754

info@nsf.ac.lk
http://www.nsf.ac.lk/

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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