Plain English Summary
Background and study aims
It has been shown that high energy nutritional supplements are very effective in treating malnutrition in developing countries. They promote weight gain and increase in energy intake, improves lipid profile and micronutrient status. This study aims to determine the effect of high-energy, nutritional supplements on appetite, energy intake, lipid profile and micronutrient status of women who become pregnant for the first time.
Who can participate?
Women aged 15-45 years who are pregnant for the first time.
What does the study involve?
After taking consents from ethical committee of KMU & the respected tertiary care hospital, women will be selected according to inclusion criteria. The information/ protocols of the study will be discussed in detail with the participants and the hospital authorities. Participants will be randomly allocated to one of two groups either receiving the supplements or placebo,which will be delivered by the main investigator on weekly basis,& empty sachets of supplements will be collected to check the compliance of the participants.The participants will be asked to make three visits ,a baseline trial,week 16 of gestation & a post natal visit On baseline trial day,the participants will be asked to visit the clinical trial room of KMU in fasting state, fasting state blood samples will be collected & appetite questionnaire will be marked& then, they will be provided with supplement/placebo & again blood samples collected & appetite questionnaires will be marked 30 minutes after supplementation and then with ad libitum buffet breakfast and ad libitum buffet lunch at specific time intervals. Blood samples will be taken &Appetite questionnaires will be marked at 30, 60, 120, 210, 270 minutes after supplementation . The participants will be asked to consume supplements/placebo in addition to their habitual diet & antenatal treatment.Records of their antenatal visits & treatment plus any complication will be kept.Nutritional counselling will be provided to the participants.Then fasting blood samples will be taken during week 16 of gestation & postnatally.The outcome of the pregnancy will be recorded & cord blood sample & colustrum sample will be collected & baby;s anthropometric measurement will be taken to look for the long term effect supplementation on fetal & pregnancy outcome.
What are the possible benefits and risks of participating?
There will be no major benefits or risk of participating. The information collected during this study will give a better understanding of the effect of supplementation during pregnancy. As dietary counseling is a fundamental and effective part of the treatment of malnutrition, the participants will get nutritional counseling on the completion of the study. As for risks, there might be a small bruise on skin from where the blood is taken.
Where is the study run from?
The study is run from the main tertiary care hospitals of Khyber Pakhtunkhwa province in Pakistan.
When is the study starting and how long is it expected to run for?
november 2017 to november2023
Who is funding the study?
Khyber Medical University Peshawar (Pakistan)
Who is the main contact?
Dr Kalsoom Tariq
drkalsoomtariq@yahoo.com
Dr Sadia Fatima
drsadiafatima@gmail.com
Dr Rubina nazli
drrubinanazli.ibms@kmu.edu.pk
Study website
Contact information
Type
Public
Contact name
Dr Kalsoom Tariq
ORCID ID
Contact details
Biochemistry Department
Institute of Basic Medical Sciences
Khyber Medical University
PDA Building
Block IV
Phase 5
Hayatabad
Peshawar
25000
Pakistan
Peshawar
25000
Pakistan
Type
Scientific
Contact name
Dr Sadia Fatima
ORCID ID
Contact details
Biochemistry Department
Institute of Basic Medical Sciences
Khyber Medical University
PDA Building
Block IV
Phase 5
Hayatabad
Peshawar
25000
Pakistan
Peshawar
25000
Pakistan
Type
Scientific
Contact name
Prof Rubina Nazli
ORCID ID
Contact details
Biochemistry Department
Institute of Basic Medical Sciences
Khyber Medical University
PDA Building
Block IV
Phase 5
Hayatabad
Peshawar
25000
Pakistan
Peshawar
25000
Pakistan
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Effect of high energy nutritional supplements on appetite regulators, energy intake and lipid profile in underweight primigravida
Acronym
Study hypothesis
The use of oral high energy nutritional supplements by the underweight healthy primigravida improves voluntary oral intake, appetite, appetite hormones, lipid profile and pregnancy outcome.
Ethics approval(s)
Not provided at time of registration. An application has been made to the ethical approval committee of Khyber Medical University.
Study design
Single-blinded randomized placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
See additional files
Condition
Low weight in women who are pregnant for the first time
Intervention
After participants are recruited, written informed consent and a detailed medical history will be taken to exclude chronic illness, eating disorders, and major gastrointestinal operations. Each participant will be asked to participate in three main experimental trials conducted at baseline, 16th week of gestation and post-natally. In addition to antenatal treatment & supplements/placebo the participants will also be provided with nutritional counseling. At the beginning of the trial, the participants will be randomly allocated to receive either a high energy nutritional supplement or placebo by computerized randomization using free software (Research Randomiser version 3). On the baseline experimental day, the participant will be requested to visit the clinical trial room at Khyber Medical University, Peshawar. Participants will be provided with 10 minutes to rest and acclimatize with the environment and then anthropometric measurements will be taken. Afterwards baseline blood samples will be collected and an appetite questionnaire will be marked. Blood samples and data on appetite will be obtained in the fasted state, 30 min after supplementation and at 60, 120, 210 and 270 min. Participants will be provided with ad libitum buffet breakfast and ad libitum lunch. A complete record of antenatal visits and routine antenatal investigations including maternal mortality, maternal anemia (Hb<10 g/dl), miscarriage (loss of pregnancy before 28 weeks of gestation), placental abruption, pre-eclampsia, mode of delivery and congenital anomalies will be maintained by the researcher. Participants will be asked to consume the supplements/placebo in addition to their habitual diet and antenatal treatments including supplements prescribed by their doctor throughout the pregnancy and one week after the delivery. The supplements will be delivered on weekly basis. The participants will be asked not to discard the empty bottles of the supplements/placebo after utilization, which will be collected in the following week in order to check the compliance. Any left over in the bottle will be recorded. Then again during the 16th week of gestation and postnatal visit fasting blood will be taken and tests will be repeated .
Intervention type
Supplement
Primary outcome measure
1. Energy consumed during the days prior to experimental trial and during ad libitum breakfast and lunch calculated using dietary analysis software (Windiets 2005, The Robert Gordon University, Aberdeen, Scotland, UK)
2. Appetite measured using a validated appetite questionnaire at baseline, week 16 and postnatally
3. Lipid profile analyzed using Cobas C3 analyzer
4. Maternal hemoglobin, hematocrit and mean corpuscular volume measured by hematology analyzer at baseline, week 16 & potnatal visit
5. Pregnancy outcome
6. Iron, zinc and calcium levels in cord blood analyzed by atomic absorption spectrometry (AAS)
7. Iron, zinc and calcium levels in colostrum measured by Cobas 8000 Modular Analyzer
Secondary outcome measures
1. Maternal satisfaction and compliance
2. Socioeconomic data
Overall study start date
01/11/2017
Overall study end date
01/11/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy
2. First pregnancy
3. Body mass index <18.5 kg/m2
4. Aged 15-45 years
Participant type(s)
Healthy volunteer
Age group
Mixed
Sex
Female
Target number of participants
12 in each group
Participant exclusion criteria
1. Major illness such as gestational diabetes mellitus, pregnancy-induced hypertension, thyroid disease or liver disease
2. Previously on any long-term medication.
3. Allergic to supplement ingredients.
4. Previous history of gastrointestinal tract anomalies, surgeries and any other eating disorders e.g. bulimia nervosa, anorexia nervosa and purging disorders
Recruitment start date
01/04/2018
Recruitment end date
24/01/2019
Locations
Countries of recruitment
Pakistan
Study participating centre
clinical trial room of KMU & tertiary care hospitals of khyber pukhtoon khwa
Hayatabad medical complex ,Peshawar
Khyber teaching hospital,Peshawar
Lady reading hospital,Peshawar
The woman's hospital,Peshawar
Peshawar
25000
Pakistan
Sponsor information
Organisation
Khyber medical university
Sponsor details
Institute of Basic Medical Sciences
Khyber Medical University
PDA Building
Block IV
Phase 5
Hayatabad
Peshawar
25000
Pakistan
Peshawar
25000
Pakistan
Sponsor type
University/education
Website
ROR
Funders
Funder type
Not defined
Funder name
Khyber medical university
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
01/10/2023
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/04/2019 | No | Yes | ||
| Results article | 01/02/2023 | 21/02/2023 | Yes | No | |
| Results article | 22/12/2021 | 28/11/2023 | Yes | No |
Additional files
- ISRCTN10088578_PIS.docx Uploaded 01/04/2019