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Home » Trials » SLCTR/2014/020

Zinc supplementation in obesity: a randomized, double- blind, placebo-controlled clinical trial

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SLCTR Registration Number

SLCTR/2014/020

Date of Registration

18 Sep 2014

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

Zinc supplementation in obesity: a randomized, double- blind, placebo-controlled clinical trial

Public Title of Trial

Effects of Zn supplementation on obesity management in adults

Disease or Health Condition(s) Studied

None

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1156-1220

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

ERC/12/007 (Ethics Review Committee of the Sri Lanka Medical Association)


Trial Details

What is the research question being addressed?

Will supplementation of Zinc (20mg) improve components of metabolic syndrome and body weight in obese adults?

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

Participants will be recruited from the Wayamba University of Sri Lanka, and surrounding area i.e.Makandura, Pannala and Kuliyapitiya

They will be randomized using stratified random sampling considering age and gender into intervention and control arms.

The intervention arm will receive 20mg elemental Zinc daily for a period of three months. The control arm will receive an identical placebo to be taken daily for three months.

Inclusion criteria

  1. 18 years – 60 years apparently healthy both males and females
  2. Body mass index (BMI) > 25 kg/m-2

Exclusion criteria

  1. Subjects on any other vitamin or mineral supplementation
  2. Current use of a weight loss medicine or dietary modification
  3. History of diabetes mellitus or any metabolic disease
  4. Alcohol consumption > 20 g/day
  5. Presently having acute diseases or other untreated illness requiring treatment
  6. Impaired hepatic or renal functions
  7. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child-bearing years
  8. History or presence of any condition, in the investigator’s opinion, that would endanger the individual’s safety or affect the study result.

Primary outcome(s)

1.
  1. Body weight
  2. Body mass index
  3. Waist circumference
  4. Waist to hip ratio
 [

At baseline and 3 months

]

Secondary outcome(s)

1.
  1. Fasting blood glucose
  2. Lipid profile (LDLC, HDLC, TAG)
  3. Systolic (SBP) and diastolic blood pressure (DBP)
 [

At baseline and 3 months

]

Target number/sample size

80 (40 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2014-09-29

Anticipated end date

2014-12-29

Date of first enrollment

2016-02-22

Date of study completion

Recruitment status

Recruiting

Funding source

Wayamba University of Sri Lanka research grant - SRHDC/RP/01/10-14

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2012-11-16

Approval number

ERC/12-007

Details of Ethics Review Committee

Name: Ethics Review Committee, Sri Lanka Medical Association
Institutional Address:No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka
Telephone:+94-11-2693324
Email: erc.slma@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Kumari M. Rathnayake
Senior Lecturer
Department of Applied Nutrition Faculty of Livestock, Fisheries and Nutrition Wayamba University of Sri Lanka Makandura (60170), Sri Lanka
0312298120


rldk_rathnayake@yahoo.com

Contact Person for Public Queries

Dr. Ranil Jayawardena
Clincal Nutritionist
Diabetes Research Unit, Faculty of Medicine, University of Colombo.
0112695300
0718323332

ranil7@gmail.com

Primary study sponsor/organization

University research grants scheme

Wayamba University of Sri Lanka, Kuliyapitiya, 60200, Sri Lanka
Tel: 037 2282758
Fax: 037 2281392

http://www.wyb.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


  • Trial Options