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

THE EFFECT OF PUMPKIN SEED EXTRACT CAPSULES (Cucurbita Moschata Durch) ON NUTRITIONAL STATUS AND HAEMOGLOBIN LEVEL IN PREGNANT WOMEN TO PREVENTION STUNTING ; A PROTOCOL OF RANDOMIZED CONTROLLED TRIAL STUDY

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

Study Overview

• Status: Recruiting
• Conditions: Anemia During Pregnancy
• Intervention / Treatment: Dietary supplement: Pumpkin seeds extract capsules

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rosdiana Syakur; Phone Number: +6285299856839; Email: rosdianaary@gmail.com

Study Locations

• Indonesia
  • South Sulawesi
    • Bone, South Sulawesi, Indonesia, 90000
      • Recruiting
      • Stunting Locus Village
      • Contact: Fakhri Kahfi; Phone Number: +6285279093174; Email: fakhrialkahfi10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 37 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pumpkin seed extract capsules; . In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks	Dietary supplement: Pumpkin seeds extract capsules; the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks
Placebo Comparator: Iron tablets; the control group received iron tablets for 12 weeks	Dietary supplement: Pumpkin seeds extract capsules; the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status	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	12 weeks
hemoglobin levels	Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.	12 weeks

Collaborators and Investigators

• Sponsor: Dr. Rosdiana Syakur
• Collaborators: Hasanuddin University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Anticipated): January 25, 2023
• Study Completion (Anticipated): August 25, 2023

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Indonesia TimurU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be shared with other researchers when study is done
• IPD Sharing Time Frame: when the study is done
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No