Condition category
Pregnancy and Childbirth
Date applied
05/03/2018
Date assigned
27/03/2018
Last edited
26/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

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

Additional contact

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

Additional contact

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 number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

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

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Phase

Drug names

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 trial start date

01/11/2017

Overall trial 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

Healthy volunteer

Age group

Mixed

Gender

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

01/04/2021

Locations

Countries of recruitment

Pakistan

Trial 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

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

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes