Effect of nutritional supplements in moderate underweight children

• Register: ISRCTN
• Last refreshed on: 30 May 2022
• Main ID: ISRCTN14718521
• Date of registration: 16/01/2018
• Prospective Registration: No
• Primary sponsor: Khyber Medical University Peshawar
• Public title: Effect of nutritional supplements in moderate underweight children
• Scientific title: Effect of nutritional supplements on energy intake, appetite, lipid profile and micronutrient status of moderate underweight children
• Date of first enrolment: 20/12/2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14718521
• Study type: Interventional
• Study design: Single blind randomised controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Pakistan

Contacts

• Name: Sadia Fatima

• Name: Aqsa Zubair

Key inclusion & exclusion criteria

Inclusion criteria:
1. 5-10 years old
2. Underweight; moderate with -2 and -3 BMI Z score

Exclusion criteria:
1. Eating disorder
2. Allergic to supplements or any food allergy
3. Gastro-intestinal tract surgery
4. Gastrointestinal tract disorders
5. Previously taking any supplement regularly
6. Previously taking such medications that interacts with appetite


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Moderate Malnutrition
Nutritional, Metabolic, Endocrine
Moderate Malnutrition

Intervention(s)

The participants are randomly allocated to either receiving Ready to Use Supplementary Food (RUSF) (Acha Mum, provided by WFP) or to the Placebo group.

After taking consents from participants, data for multiple pass 24 hours dietary recalls are taken for 3 consecutive days (including a Sunday) before the actual trial day. On trial day the participants come to clinical trial room in KMU. The anthropometric measurements, data on appetite and the baseline blood samples in a fasted state is obtained in the morning. Then the supplement (Acha Mum by WFP) /placebo os provided. Further appetite questionnaire aremarked at time interval of 30 and 60 minutes. An ad libitum buffet breakfast and ad libitum buffet lunch are presented at 90 and 240 minutes after provision of supplements respectively. Again at 120, 150, 180 and 210 minutes, appetite questionnaires is marked after the supplementation. Four researchers measure the energy intake during the breakfast and lunch to enhance the accuracy of the results. “Windiet® software” are used to calculate the total caloric intake.

The participants are given either the supplement or placebo for 30 days on daily basis by main researchers. On thirty-first day, anthropometric measurements and fasting blood samples are collected again from both groups and the procedure are repeated as explained above.

The total duration of the intervention is 4 weeks.

Primary Outcome(s)

1. Weight is measured using a calibrated electronic scale at baseline and four weeks
2. Height is measured using with a portable stadiometer (Seca, Leicester, UK) using a stretch stature method at baseline and four weeks
3. Mid upper arm circumference is measured using the Shakir measuring tape on the “non dominant hand” at baseline and four weeks
4. Skin fold measurement is measured using a Holtain skin fold calliper (Holtain LTD, Crosswell, UK) to the nearest 0.2 mm at baseline and four weeks
5. Appetite is measured using a validated appetite questionnaire at baseline and four weeks
6. Head circumference is measured using the Lasso-o measuring tape at baseline and four weeks
7. Waist to hip ratio is measured using Lasso-o measuring tape at baseline and four weeks
8. Energy intake will be measured using Windiet® software
9. Lipid profile will be analyzed using Cobas C3 analyzer
10. Hemoglobin (Hb) levels are checked by using hematology analyzer
11. Status of Iron (Fe), zinc (Zn) and copper (Cu) in plasma are analyzed by atomic absorption spectrometry (AAS)
12. Vitamin D and Calcium (Ca) levels are checked using a Cobas 8000 Modular Analyzer.

Secondary Outcome(s)

1. Taste acceptability of supplements is measured using validated sensory evaluation questionnaires at baseline and four weeks
2. Perceived benefits of the supplements by parents/carers are measured using validated parent perception questionnaires at baseline and four weeks
3. Perceived side effects of the supplements by parents/carers measured using validated parent perception questionnaires at baseline and four weeks
4. Socio-economic status of participant will be categorized using validated demographic questionnaire

Secondary ID(s)

N/A

Source(s) of Monetary Support

Khyber Medical University Peshawar

Ethics review

Status:
Approval date:
Contact:

The Research Ethics Committee of Institute of Basic Medical Sciences, Khyber Medical University Peshawar, 09/02/2017

Results

• Results available: Yes
• Date Completed: 30/04/2020