The Effect Of Pumpkin Seed Extract Capsules On Nutritional Status and Haemoglobin Level in Pregnant Women.

Early Phase 1

Recruiting

• Conditions: Anemia During Pregnancy
• Interventions: Dietary Supplement: Pumpkin seeds extract capsules

• Registration Number: NCT05657821
• Lead Sponsor: Dr. Rosdiana Syakur

Brief Summary

The goal of this to measure the effect of supplementation of Yellow Pumpkin Seed Extract Capsules in pregnant women on hemoglobin levels and nutritional status of pregnant women.

The main question\[s\] it aims to answer are:

* is there a difference in changes in nutritional status (increase in body weight and MUAC) in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets

* is there a difference in changes in hemoglobin levels in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets.

The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks

Detailed Description

This study was designed with an experimental method using a randomized double blind with a control group. The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks. The research will be conducted in the village of the stunting locus, Bone Regency, South Sulawesi, Indonesia. Data analysis was carried out with SPSS, where to see the difference between the intervention group and the contro group, a paired t test was used if the data was normally distributed and an alternative test if the data was not normally distributed.

Study Timeline

• Study Start: 2022-10-25
• Status Verified: 2022-12
• Study First Submitted: 2022-12-11
• Study First Submitted QC: 2022-12-11
• Last Update Submitted: 2022-12-11
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2023-01-25
• Study Completion: 2023-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. in the one or second trimester of pregnancy;
2. having no complications;
3. willing to participate in this study;
4. domiciled in the stunting locus village Bone regency .

Exclusion Criteria

• Pregnant women with complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pumpkin seed extract capsules	Pumpkin seeds extract capsules	. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks
Iron tablets	Pumpkin seeds extract capsules	the control group received iron tablets for 12 weeks

Primary Outcome Measures

Name	Time	Method
Nutritional status	12 weeks	measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out
hemoglobin levels	12 weeks	Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.

Trial Locations

Locations (1)

Stunting Locus Village; 🇮🇩 Bone, South Sulawesi, Indonesia