AzTrials
AzTrials

Celiac Disease in ChildrenNCT06359613

Efficacy Assessment of Gluten Free Cupcakes

A study testing nutrient rich food product and food product in people with Celiac Disease in Children, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). Read more about this study

Who is it for?
Ages 3 to 8 years
Conditions the study is for
Celiac Disease in Children
What is being tested?
nutrient rich food product and food product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 sitePakistan
Study dates
3 Oct 2019to 3 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Positive tissue trans-glutaminase antibody (tTG)
  • Clinical response to gluten free diet

Who cannot join

  • Vitamins and mineral supplements
  • Intestinal inflammatory diseases
  • Malignant diseases of intestines
  • Chronic infections,
  • Thyroid, renal or hepatic alterations
  • Celiac patients with diabetes
  • Taking drugs known to effect lipid and /or carbohydrate metabolism

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • UVAS

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Development and Efficacy Assessment of Aglutenic Product to Improve the Nutritional Status of Celiac Children

Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ).

Read the detailed description

Raw Material/ Preparation of flour blends for aglutenic (gluten free) cupcakes:

Sorghum, chickpea, Flaxseed and Almond rich in healthy nutrients will be purchased from the local market. All these ingredients was ground into fine powder using uncontaminated grinder. Different flour blends was prepared by substituting whole wheat flour with Sorghum, Chickpea, Flaxseed and Almond flour at different replacement levels.

The efficacy study protocol was approved by the Bioethics Committee for randomized controlled trial (RCT). Written informed consent was obtained by the parents of children or their legal guardian.

Target population: Celiac Disease/gluten sensitive patients (n= 70, 35 control + 35 intervention) was recruited according to European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.

Inclusion criteria:

In accordance with the inclusion criteria, boys and girls suffering from celiac disease was recruited:

  • Positive trans-glutaminase antibody (tTG) as currently recommended test is the serum Immunoglobulin A (IgA) tissue trans-glutaminase antibody (tTG). The test has a sensitivity and specificity of greater than 90%.
  • Clinical response to gluten free diet
  • In the age range of 3-8 years

Exclusion Criteria:

  • Patients on any other designed diet
  • Taking vitamins and mineral supplements
  • Individuals presenting with any other intestinal inflammatory disease, malignant diseases, chronic infections, thyroid, renal or hepatic alterations
  • Taking drugs known to effect lipid and /or carbohydrate metabolism will be excluded from the study.

Effect of interventional product on nutritional status of participants will be assessed through anthropometric measurements, gastrointestinal complaints and following hematological indices;

  • Complete Blood Count (CBC) WBCs, RBCs, MCV, Hb. , Hct. , Platelets
  • Total Protein
  • Lipid Profile HDL, LDL, VLDL, Cholesterol
  • SGPT, SGOT
  • Serum Electrolytes (Na ,Ca, K)
Being tested
nutrient rich food product, food product
Keywords
gluten sensitivity children nutritional status food choices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nutrient rich food productDietary supplement

    Cupcakes from flour blends of Sorghum, chickpea, Flaxseed and Almond will be prepared and flour concentration will be so adjusted to provide >20% daily value of nutrients for children of 3-8 years of age. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.

  • food productDietary supplement

    Cupcakes from usually used gluten free rice flour will be prepared. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.

Study groups in NCT06359613
Study groupRoleWhat they receive
Gluten Free cupcake GroupExperimentalNutrient rich food product (cupcakes) from flour blends of Sorghum, chickpea, Flaxseed and Almond will be prepared and flour concentration will be so adjusted to provide >20% daily value of nutrients for children of 3-8 years of age. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.
Receives: Dietary Supplement: nutrient rich food product
Placebo groupPlacebo comparatorCupcakes from usually used gluten free rice flour will be prepared. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.
Receives: Dietary Supplement: food product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight

    Body weight (in kilograms) will be measured using a weight machine with standardization done after every 20 readings.

    Measured: 12 weeks

  2. Height of the patients

    Height (in centimeters) will be measured (without shoes) in the position, back and hips touching the wall by using wall mounted stedio-meter

    Measured: 12 weeks

  3. Mid upper Arm Circumference (MUAC)

    Mid-upper arm circumference (MUAC) in centimeters will be measured midpoint between the acromion process of the scapula and the tip of the elbow.

    Measured: 12 weeks

  4. Body Mass Index (BMI)

    BMI will be calculated by using standard formula as weight in kilograms divided by height in meter square kg/m2. World Health Organization (WHO) standard growth charts, designed separately for boys and girls will be used as a research tool to assess the nutritional status.

    Measured: 12 weeks

  5. Complete Blood Count (CBC)

    White Blood Cells 10^9/L Red Blood Cells million/mm3 Mean Corpuscular Volume 10^6/µL Hemoglobin g/dL Hematocrit % Platelets 10^9/L

    Measured: 12 weeks

  6. Total Protein

    Serum Total Protein g/dL

    Measured: 12 weeks

  7. Lipid Profile

    High Density Lipoproteins mg/dL Low Density Lipoproteins mg/dL Very Low-Density Lipoproteins mg/dL Serum Total Cholesterol mg/dL

    Measured: 12 weeks

  8. Liver Enzymes

    serum glutamic-pyruvic transaminase SGPT- U/L, serum glutamic-oxaloacetic transaminase SGOT-U/L

    Measured: 12 weeks

  9. Serum Electrolytes

    Sodium mmol/L Calcium mg/dL Potassium mmol/L

    Measured: 12 weeks

Secondary outcomes (1)

  1. Gastrointestinal Symptoms

    Rate of diarrhea, constipation, Severity of abdominal pain, steatorrhea, flatulence and appetite will be monitored by using Gastrointestinal Rating Scale with addition of Steatorrhea.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start3 Oct 2019
  3. Primary completion15 Dec 2019
  4. Study completion3 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The product will be provided to intervention group (n=50) in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2/day) providing approximately 20%DV of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group (n=50)
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359613
Sponsor's protocol ID
029/IRC/BMR
Status last verified
Apr 2024
First submitted
29 Mar 2024
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: study outcomes will be shared with other researchers through publication without personal identification

Publications

  • Suliburska J, Krejpcio Z, Regula J, Grochowicz A. Evaluation of the content and the potential bioavailability of minerals from gluten-free products. Acta Sci Pol Technol Aliment. 2013 Jan-Mar;12(1):75-9.

    PubMed 24584867

Questions about this trial

What is this clinical trial studying?

A study testing nutrient rich food product and food product in people with Celiac Disease in Children, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06359613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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