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A Randomized Controlled Trial to find out the effectiveness of four weeks of zinc supplements on patients with newly diagnosed celiac disease on three months of gluten free diet.

Serum Zinc,Copper and Iron status of children with newly diagnosed celiac disease on three months of gluten free diet with or without four weeks of zinc supplements-A Randomized Controlled Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/06/003785
Enrollment
66
Registered
2013-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Newly Diagnosed Patients of Celiac Disease

Interventions

Intervention1: Gluten Free Diet with Zinc supplementation: Gluten free diet with T.Zinc 2mg/kg(maximum dose-20mg)daily in a single dose orally for four weeks, from the day of starting GFD Control Inte

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed caese of celiac disease as per revised ESPGHAN criteria(Positive Celiac serology along with partial or total villous atrophy) Age less than 18 years

Exclusion criteria

Exclusion criteria: Refusal of informed consent Newly diagnosed Celiac Disease patients who has received zinc supplements in last 3 months Clinical signs of Acrodermatitis Enteropathica

Design outcomes

Primary

MeasureTime frame
To compare mean rise of serum zinc at 3 months after diagnosis in children with Celiac disease receiving GFD and four weeks of zinc supplementation as compared to children on GFD without zinc supplementsTimepoint: At the time of diagnosis At 3 months

Secondary

MeasureTime frame
To compare the proportion of children with normal serum copper and iron status at 3 months after diagnosis in children with Celiac disease receiving GFD and four weeks of zinc supplementation as compared to children on GFD without zinc supplementsTimepoint: At the time of diagnosis At 3 months;To compare the proportion of children with normal serum zinc level at 3 months after diagnosis in children with Celiac disease receiving GFD and four weeks of zinc supplementation as compared to children on GFD without zinc supplementsTimepoint: At the time of diagnosis At 3months;To compare weight gain at 3 months after diagnosis in children with Celiac disease receiving GFD and four weeks of zinc supplementation as compared to children on GFD without zinc supplementsTimepoint: At the time of diagnosis At 3 months

Countries

India

Contacts

Public ContactDr Praveen Kumar

Kalawati Saran Childrens Hospital

pkpaed@gmail.com9868579672

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026