Home » Trials » SLCTR/2007/007


Folate status in two groups of pregnant and non-pregnant/ non-lactating women in Sri Lanka -

SLCTR Registration Number

SLCTR/2007/007


Date of Registration

14 Jun 2007

The date of last modification

Feb 22, 2013


Trial Status



Application Summary


Scientific Title of Trial

Folate status in two groups of pregnant and non-pregnant/ non-lactating women in Sri Lanka


Public Title of Trial

Folic acid status in Sri Lanka in pregnant and lactating women


Disease of Health Condition(s) Studied

Folate status in relation to pregnancy and lactation


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


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

IAEA-SRL-11958, research grant sponsor - International Atomic Energy Agency


Trial Details


What is the research question being addressed?

Does lactation have any influence on folate status in women who are supplemented with or without folic acid upto six months of lactation?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose


Intervention(s) planned

Pregnant women (n=200) who are at present participating in an ongoing study will be followed up for a period of six months post partum.

The pregnant women who are enrolled will be divided into two groups based on their follow-up center; i.e. pregnant women selected from MCH clinics and pregnant women from TH-Mahamodara. Then folate supplementation will be continued for a period of six months post partum to the MCH group only. Their folate status at the end of supplementation will be compared with that of non supplemented lactating women of TH Mahamodara group.


Inclusion criteria

Healthy pregnant women who come for the booking visit and ante-natal clinic


Exclusion criteria

Severely anaemic and iron deficient pregnant women



Primary outcome(s)

Improvement in folate status of women during early lactation


Primary outcome(s) - Time of assessment(s)

At the end of the study : March 2008


Secondary outcome

•Improvement in folate status of lactating mothers and infants •Improving awareness on general nutritional status of the community


Secondary outcome(s) - Time of assessment(s)

•Improvement in folate status of lactating mothers and infants •Improving awareness on general nutritional status of the community



Target number/sample size

200 (100 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2007-04-30


Anticipated end date

2007-10-31


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Ruhuna


Funding source

International Atomic Energy Agency (IAEA)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Chandrani Liyanage
Prof in Community Medicine & Head Nuclear Medicine
Nuclear Medicine Unit, Faculty of Medicine, University of Ruhuna, Galle
+94 91 2234801

+94 91 2222314
nmu_galle@yahoo.com

Contact Person for Public Queries

Prof. Chandrani Liyanage
Prof in Community Medicine & Head Nuclear Medicine
Nuclear Medicine Unit, Faculty of Medicine, University of Ruhuna, Galle
+94 91 2234801

+94 91 2222314
nmu_galle@yahoo.com


Primary study sponsor/organization

IAEA research grant SRL 11958

Nutrition and Health related Environmental Studies Division, IAEA, Vienna, Austria


Officialmail@iaea.org
www.iaea.org

Secondary study sponsor (If any)

None