Home » Trials » SLCTR/2007/007
Folate status in two groups of pregnant and non-pregnant/ non-lactating women in Sri Lanka
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SLCTR Registration Number
SLCTR/2007/007
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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 or Health Condition(s) Studied
Folate status in relation to pregnancy and lactation
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
IAEA-SRL-11958, research grant sponsor - International Atomic Energy Agency
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/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
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)
|
1.
Improvement in folate status of women during early lactation |
[ At the end of the study : March 2008 ] |
Secondary outcome(s)
|
1.
•Improvement in folate status of lactating mothers and infants •Improving awareness on general nutritional status of the community |
[ Throughout the research programme i.e., April 2007 to March 2008 ] |
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
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
International Atomic Energy Agency (IAEA)
Regulatory approvals
Status
Approved
Date of Approval
2006-12-06
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
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
